Commonwealth Coat of Arms of Australia

 

PB 14 of 2024

 

National Health Legislation Amendment (Maximum Dispensed Quantities) Instrument 2024
 

National Health Act 1953

 

I, NIKOLAI TSYGANOV, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated  28 February 2024

NIKOLAI TSYGANOV

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

 

 

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Maximum dispensed quantities

National Health (Listing of Pharmaceutical Benefits) Instrument 2012. 2

1 Name

(1)          This instrument is the National Health Legislation Amendment (Maximum Dispensed Quantities) Instrument 2024.

(2)          This instrument may also be cited as PB 14 of 2024.

2 Commencement

(1)          Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

1 March 2024

1 March 2024

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)          Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

4 Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Maximum dispensed quantities

National Health (Listing of Pharmaceutical Benefits) Instrument 2012

[1]                   Schedule 1, Part 1, entry for Acarbose

substitute:

Acarbose

Tablet 50 mg

Oral

a

Acarbose Mylan

AF

MP NP

 

 

90

5

90

 

 

 

 

 

a

Acarbose Viatris

AL

MP NP

 

 

90

5

90

 

 

 

 

 

a

GLYBOSAY

RW

MP NP

 

 

90

5

90

 

 

 

 

 

a

Acarbose Mylan

AF

MP NP

 

P14238

180

5

90

 

 

 

 

 

a

Acarbose Viatris

AL

MP NP

 

P14238

180

5

90

 

 

 

 

 

a

GLYBOSAY

RW

MP NP

 

P14238

180

5

90

 

 

 

Tablet 100 mg

Oral

a

Acarbose Viatris

AL

MP NP

 

 

90

5

90

 

 

 

 

 

a

GLYBOSAY

RW

MP NP

 

 

90

5

90

 

 

 

 

 

a

Acarbose Viatris

AL

MP NP

 

P14238

180

5

90

 

 

 

 

 

a

GLYBOSAY

RW

MP NP

 

P14238

180

5

90

 

 

[2]                   Schedule 1, Part 1, entry for Alendronic acid with colecalciferol

substitute:

Alendronic acid with colecalciferol

Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

Oral

 

Fosamax Plus

MQ

MP NP

C6307 C6315 C6320 C15011 C15024 C15035

P6307 P6315 P6320

4

5

4

 

 

 

 

 

 

 

 

MP NP

C6307 C6315 C6320 C15011 C15024 C15035

P15011 P15024 P15035

8

5

4

 

 

 

Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

Oral

 

Fosamax Plus 70 mg/140 mcg

MQ

MP NP

C6306 C6319 C6325 C14898 C14993 C15032

P6306 P6319 P6325

4

5

4

 

 

 

 

 

 

 

 

MP NP

C6306 C6319 C6325 C14898 C14993 C15032

P14898 P14993 P15032

8

5

4

 

 

[3]                   Schedule 1, Part 1, entry for Alogliptin

substitute:

Alogliptin

Tablet 6.25 mg (as benzoate)

Oral

 

Nesina

TK

MP NP

C4349 C14862

P4349

28

5

28

 

 

 

 

 

 

 

 

MP NP

C4349 C14862

P14862

56

5

28

 

 

 

Tablet 12.5 mg (as benzoate)

Oral

 

Nesina

TK

MP NP

C4349 C14862

P4349

28

5

28

 

 

 

 

 

 

 

 

MP NP

C4349 C14862

P14862

56

5

28

 

 

 

Tablet 25 mg (as benzoate)

Oral

 

Nesina

TK

MP NP

C4349 C14862

P4349

28

5

28

 

 

 

 

 

 

 

 

MP NP

C4349 C14862

P14862

56

5

28

 

 

[4]                   Schedule 1, Part 1, entry for Alogliptin with metformin

substitute:

Alogliptin with metformin

Tablet containing 12.5 mg alogliptin (as benzoate) with 1 g metformin hydrochloride

Oral

 

Nesina Met 12.5/1000

TK

MP NP

C4423 C4427 C14876

P4423 P4427

56

5

56

 

 

 

 

 

 

 

 

MP NP

C4423 C4427 C14876

P14876

112

5

56

 

 

 

Tablet containing 12.5 mg alogliptin (as benzoate) with 500 mg metformin hydrochloride

Oral

 

Nesina Met 12.5/500

TK

MP NP

C4423 C4427 C14876

P4423 P4427

56

5

56

 

 

 

 

 

 

 

 

MP NP

C4423 C4427 C14876

P14876

112

5

56

 

 

 

Tablet containing 12.5 mg alogliptin (as benzoate) with 850 mg metformin hydrochloride

Oral

 

Nesina Met 12.5/850

TK

MP NP

C4423 C4427 C14876

P4423 P4427

56

5

56

 

 

 

 

 

 

 

 

MP NP

C4423 C4427 C14876

P14876

112

5

56

 

 

[5]                   Schedule 1, Part 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

substitute:

 

Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

Oral

a

Cadivast 10/80

AF

MP NP

 

 

30

5

30

 

 

 

 

 

a

Caduet 10/80

AS

MP NP

 

 

30

5

30

 

 

 

 

 

a

Cadivast 10/80

AF

MP NP

 

P14238

60

5

30

 

 

 

 

 

a

Caduet 10/80

AS

MP NP

 

P14238

60

5

30

 

 

[6]                   Schedule 1, Part 1, entry for Anastrozole

substitute:

Anastrozole

Tablet 1 mg

Oral

a

Anastrozole GH

GQ

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Anastrozole Sandoz

SZ

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

APO-Anastrozole

TX

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Arianna 1

AF

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Arimidex

AP

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Anastrozole GH

GQ

MP NP

C5464 C14943

P14943

60

5

30

 

 

 

 

 

a

Anastrozole Sandoz

SZ

MP NP

C5464 C14943

P14943

60

5

30

 

 

 

 

 

a

APO-Anastrozole

TX

MP NP

C5464 C14943

P14943

60

5

30

 

 

 

 

 

a

Arianna 1

AF

MP NP

C5464 C14943

P14943

60

5

30

 

 

 

 

 

a

Arimidex

AP

MP NP

C5464 C14943

P14943

60

5

30

 

 

[7]                   Schedule 1, Part 1, entry for Bromocriptine

substitute:

Bromocriptine

Tablet 2.5 mg (as mesilate)

Oral

 

Parlodel

SZ

MP

C5172 C6706 C6707 C6717 C6718 C6719 C6787 C14914 C14981 C15017 C15028 C15043 C15044

P5172

30

0

30

 

 

 

 

 

 

 

 

NP

C5172

 

30

0

30

 

 

 

 

 

 

 

 

MP

C5172 C6706 C6707 C6717 C6718 C6719 C6787 C14914 C14981 C15017 C15028 C15043 C15044

P6706 P6707 P6717 P6718 P6719 P6787

60

5

30

 

 

 

 

 

 

 

 

MP

C5172 C6706 C6707 C6717 C6718 C6719 C6787 C14914 C14981 C15017 C15028 C15043 C15044

P14914 P14981 P15017 P15028 P15043 P15044

120

5

30

 

 

[8]                   Schedule 1, Part 1, entry for Cabergoline in the form Tablet 500 micrograms

substitute:

Cabergoline

Tablet 500 micrograms

Oral

 

Dostinex

PF

MP

C5136 C5137 C5172 C5357 C5398 C14918 C14959 C14983 C15005

P5172

2

0

2

 

 

 

 

 

 

 

 

NP

C5172

 

2

0

2

 

 

 

 

 

 

 

 

MP

C5136 C5137 C5172 C5357 C5398 C14918 C14959 C14983 C15005

P5136 P5137 P5357 P5398

8

5

8

 

 

 

 

 

 

 

 

MP

C5136 C5137 C5172 C5357 C5398 C14918 C14959 C14983 C15005

P14918 P14959 P14983 P15005

16

5

8

 

 

[9]                   Schedule 1, Part 1, entry for Carbamazepine in the form Oral suspension 100 mg per 5 mL, 300 mL

substitute:

Carbamazepine

Oral suspension 100 mg per 5 mL, 300 mL

Oral

 

Tegretol Liquid

NV

PDP

 

 

1

0

1

 

 

 

 

 

 

 

 

MP NP

 

 

1

5

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

5

1

 

 

[10]               Schedule 1, Part 1, entry for Carbamazepine in the form Tablet 200 mg (controlled release)

substitute:

 

Tablet 200 mg (controlled release)

Oral

 

Tegretol CR 200

NV

PDP

 

 

200

0

200

 

 

 

 

 

 

 

 

MP NP

 

 

200

2

200

 

 

 

 

 

 

 

 

MP NP

 

P14238

400

2

200

 

 

[11]               Schedule 1, Part 1, entry for Carbamazepine in the form Tablet 400 mg (controlled release)

substitute:

 

Tablet 400 mg (controlled release)

Oral

 

Tegretol CR 400

NV

PDP

 

 

200

0

200

 

 

 

 

 

 

 

 

MP NP

 

 

200

2

200

 

 

 

 

 

 

 

 

MP NP

 

P14238

400

2

200

 

 

[12]               Schedule 1, Part 1, entry for Carbimazole

substitute:

Carbimazole

Tablet 5 mg

Oral

a

Neo-Mercazole

GH

MP NP

 

 

200

2

100

 

 

 

 

 

a

THIRAZOL

NB

MP NP

 

 

200

2

100

 

 

 

 

 

a

WP Carbimazole

TN

MP NP

 

 

200

2

100

 

 

 

 

 

a

Neo-Mercazole

GH

MP NP

 

P14238

400

2

100

 

 

 

 

 

a

THIRAZOL

NB

MP NP

 

P14238

400

2

100

 

 

 

 

 

a

WP Carbimazole

TN

MP NP

 

P14238

400

2

100

 

 

[13]               Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 10 mg

substitute:

Ciclosporin

Capsule 10 mg

Oral

 

Neoral 10

NV

MP

 

 

120

3

60

 

 

 

 

 

 

 

 

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

120
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

60

 

C(100)

 

 

 

 

 

 

MP

 

P14238

240

3

60

 

 

[14]               Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 25 mg

substitute:

 

Capsule 25 mg

Oral

a

APO-Ciclosporin

TX

MP

 

 

60

3

30

 

 

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

 

60

3

30

 

 

 

 

 

a

Neoral 25

NV

MP

 

 

60

3

30

 

 

 

 

 

a

APO-Ciclosporin

TX

MP

 

P14238

120

3

30

 

 

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

P14238

120

3

30

 

 

 

 

 

a

Neoral 25

NV

MP

 

P14238

120

3

30

 

 

 

 

 

a

APO-Ciclosporin

TX

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

120
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

30

 

C(100)

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

120
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

30

 

C(100)

 

 

 

a

Neoral 25

NV

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

120
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

30

 

C(100)

[15]               Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 50 mg

substitute:

 

Capsule 50 mg

Oral

a

APO-Ciclosporin

TX

MP

 

 

60

3

30

 

 

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

 

60

3

30

 

 

 

 

 

a

Neoral 50

NV

MP

 

 

60

3

30

 

 

 

 

 

a

APO-Ciclosporin

TX

MP

 

P14238

120

3

30

 

 

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

P14238

120

3

30

 

 

 

 

 

a

Neoral 50

NV

MP

 

P14238

120

3

30

 

 

 

 

 

a

APO-Ciclosporin

TX

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

120
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

30

 

C(100)

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

120
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

30

 

C(100)

 

 

 

a

Neoral 50

NV

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

120
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

30

 

C(100)

[16]               Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 100 mg

substitute:

 

Capsule 100 mg

Oral

a

APO-Ciclosporin

TX

MP

 

 

60

3

30

 

 

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

 

60

3

30

 

 

 

 

 

a

Neoral 100

NV

MP

 

 

60

3

30

 

 

 

 

 

a

APO-Ciclosporin

TX

MP

 

P14238

120

3

30

 

 

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

P14238

120

3

30

 

 

 

 

 

a

Neoral 100

NV

MP

 

P14238

120

3

30

 

 

 

 

 

a

APO-Ciclosporin

TX

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

120
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

30

 

C(100)

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

120
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

30

 

C(100)

 

 

 

a

Neoral 100

NV

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

120
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

30

 

C(100)

[17]               Schedule 1, Part 1, entry for Ciclosporin in the form Oral liquid 100 mg per mL, 50 mL

substitute:

 

Oral liquid 100 mg per mL, 50 mL

Oral

 

Neoral

NV

MP

 

 

2

3

1

 

 

 

 

 

 

 

 

MP

 

P14238

4

3

1

 

 

 

 

 

 

 

 

MP

 

P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168

4
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

5
CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168

1

 

C(100)

[18]               Schedule 1, Part 1, entry for Cortisone

substitute:

Cortisone

Tablet containing cortisone acetate 5 mg

Oral

 

Cortate

AS

MP NP

 

 

50

4

50

 

 

 

 

 

 

 

 

MP NP

 

P14238

100

4

50

 

 

 

Tablet containing cortisone acetate 25 mg

Oral

 

Cortate

AS

MP NP

 

 

60

4

60

 

 

 

 

 

 

 

 

MP NP

 

P14238

120

4

60

 

 

[19]               Schedule 1, Part 1, entry for Cyproterone

substitute:

Cyproterone

Tablet containing cyproterone acetate 50 mg

Oral

a

ANTERONE 50

RW

MP

 

P5532

20
CN5532

5
CN5532

20

 

 

 

 

 

a

Cyproterone Sandoz

HX

MP

 

P5532

20
CN5532

5
CN5532

20

 

 

 

 

 

a

Pharmacor Cyproterone 50

CR

MP

 

P5532

20
CN5532

5
CN5532

20

 

 

 

 

 

a

ANTERONE 50

RW

MP

 

P14868

40
CN14868

5
CN14868

20

 

 

 

 

 

a

Cyproterone Sandoz

HX

MP

 

P14868

40
CN14868

5
CN14868

20

 

 

 

 

 

a

Pharmacor Cyproterone 50

CR

MP

 

P14868

40
CN14868

5
CN14868

20

 

 

 

 

 

a

Androcur

BN

MP

 

 

100

5

50

 

 

 

 

 

a

ANTERONE 50

RW

MP

 

 

100

5

50

 

 

 

 

 

a

Cyproterone Sandoz

HX

MP

 

 

100

5

50

 

 

 

 

 

a

Pharmacor Cyproterone 50

CR

MP

 

 

100

5

50

 

 

 

 

 

a

Androcur

BN

MP

 

P14238

200

5

50

 

 

 

 

 

a

ANTERONE 50

RW

MP

 

P14238

200

5

50

 

 

 

 

 

a

Cyproterone Sandoz

HX

MP

 

P14238

200

5

50

 

 

 

 

 

a

Pharmacor Cyproterone 50

CR

MP

 

P14238

200

5

50

 

 

 

Tablet containing cyproterone acetate 100 mg

Oral

a

Androcur-100

BN

MP

 

 

50

5

50

 

 

 

 

 

a

ANTERONE 100

RW

MP

 

 

50

5

50

 

 

 

 

 

a

Cyproterone Sandoz

HX

MP

 

 

50

5

50

 

 

 

 

 

a

Pharmacor Cyproterone 100

CR

MP

 

 

50

5

50

 

 

 

 

 

a

Androcur-100

BN

MP

 

P14238

100

5

50

 

 

 

 

 

a

ANTERONE 100

RW

MP

 

P14238

100

5

50

 

 

 

 

 

a

Cyproterone Sandoz

HX

MP

 

P14238

100

5

50

 

 

 

 

 

a

Pharmacor Cyproterone 100

CR

MP

 

P14238

100

5

50

 

 

[20]               Schedule 1, Part 1, entry for Dapagliflozin

substitute:

Dapagliflozin

Tablet 10 mg (as propanediol monohydrate)

Oral

 

Forxiga

AP

MP

C4991 C5629 C7495 C7506 C7528 C12477 C13230 C14859 C14905 C14949 C14974 C14976

P4991 P5629 P7495 P7506 P7528 P12477 P13230

28

5

28

 

 

 

 

 

 

 

 

NP

C4991 C5629 C7495 C7506 C12477 C13230 C14859 C14905 C14949 C14974 C14976

P4991 P5629 P7495 P7506 P12477 P13230

28

5

28

 

 

 

 

 

 

 

 

MP

C4991 C5629 C7495 C7506 C7528 C12477 C13230 C14859 C14905 C14949 C14974 C14976

P14859 P14905 P14949 P14974 P14976

56

5

28

 

 

 

 

 

 

 

 

NP

C4991 C5629 C7495 C7506 C12477 C13230 C14859 C14905 C14949 C14974 C14976

P14859 P14905 P14949 P14974 P14976

56

5

28

 

 

[21]               Schedule 1, Part 1, entry for Dapagliflozin with metformin

substitute:

Dapagliflozin with metformin

Tablet (modified release) containing 5 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride

Oral

 

Xigduo XR 5/1000

AP

MP

C5631 C5657 C5739 C5798 C7492 C7498 C14878 C14881 C14924 C14987

P5631 P5657 P5739 P5798 P7492 P7498

56

5

56

 

 

 

 

 

 

 

 

NP

C5631 C5657 C5739 C5798 C7492 C14878 C14881 C14924 C14987

P5631 P5657 P5739 P5798 P7492

56

5

56

 

 

 

 

 

 

 

 

MP

C5631 C5657 C5739 C5798 C7492 C7498 C14878 C14881 C14924 C14987

P14878 P14881 P14924 P14987

112

5

56

 

 

 

 

 

 

 

 

NP

C5631 C5657 C5739 C5798 C7492 C14878 C14881 C14924 C14987

P14878 P14881 P14924 P14987

112

5

56

 

 

 

Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride

Oral

 

Xigduo XR 10/500

AP

MP

C5631 C5657 C5739 C5798 C7492 C7498 C14878 C14881 C14924 C14987

P5631 P5657 P5739 P5798 P7492 P7498

28

5

28

 

 

 

 

 

 

 

 

NP

C5631 C5657 C5739 C5798 C7492 C14878 C14881 C14924 C14987

P5631 P5657 P5739 P5798 P7492

28

5

28

 

 

 

 

 

 

 

 

MP

C5631 C5657 C5739 C5798 C7492 C7498 C14878 C14881 C14924 C14987

P14878 P14881 P14924 P14987

56

5

28

 

 

 

 

 

 

 

 

NP

C5631 C5657 C5739 C5798 C7492 C14878 C14881 C14924 C14987

P14878 P14881 P14924 P14987

56

5

28

 

 

 

Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride

Oral

 

Xigduo XR 10/1000

AP

MP

C5631 C5657 C5739 C5798 C7492 C7498 C14878 C14881 C14924 C14987

P5631 P5657 P5739 P5798 P7492 P7498

28

5

28

 

 

 

 

 

 

 

 

NP

C5631 C5657 C5739 C5798 C7492 C14878 C14881 C14924 C14987

P5631 P5657 P5739 P5798 P7492

28

5

28

 

 

 

 

 

 

 

 

MP

C5631 C5657 C5739 C5798 C7492 C7498 C14878 C14881 C14924 C14987

P14878 P14881 P14924 P14987

56

5

28

 

 

 

 

 

 

 

 

NP

C5631 C5657 C5739 C5798 C7492 C14878 C14881 C14924 C14987

P14878 P14881 P14924 P14987

56

5

28

 

 

[22]               Schedule 1, Part 1, entry for Desmopressin in the form Tablet containing desmopressin acetate 200 micrograms

substitute:

 

Tablet containing desmopressin acetate 200 micrograms

Oral

 

Minirin

FP

MP

C5266 C5295 C5413 C14842 C14972 C15012

P5295 P5413

30

5

30

 

 

 

 

 

 

 

 

NP

C5295 C5413 C14842 C14972

P5295 P5413

30

5

30

 

 

 

 

 

 

 

 

MP

C5266 C5295 C5413 C14842 C14972 C15012

P14842 P14972

60

5

30

 

 

 

 

 

 

 

 

NP

C5295 C5413 C14842 C14972

P14842 P14972

60

5

30

 

 

 

 

 

 

 

 

MP

C5266 C5295 C5413 C14842 C14972 C15012

P5266

90

5

30

 

 

 

 

 

 

 

 

MP

C5266 C5295 C5413 C14842 C14972 C15012

P15012

180

5

30

 

 

[23]               Schedule 1, Part 1, entry for Desmopressin in the form Wafer 120 micrograms (as acetate)

substitute:

 

Wafer 120 micrograms (as acetate)

Sublingual

 

Minirin Melt

FP

MP NP

C5226 C5412 C14842 C14972

P5226 P5412

30

5

30

 

 

 

 

 

 

 

 

MP NP

C5226 C5412 C14842 C14972

P14842 P14972

60

5

30

 

 

[24]               Schedule 1, Part 1, entry for Desmopressin in the form Wafer 240 micrograms (as acetate)

substitute:


 

Wafer 240 micrograms (as acetate)

Sublingual

 

Minirin Melt

FP

MP NP

C5226 C5412 C14945 C15025

P5226 P5412

30

5

30

 

 

 

 

 

 

 

 

MP NP

C5226 C5412 C14945 C15025

P14945 P15025

60

5

30

 

 

[25]               Schedule 1, Part 1, entry for Dexamethasone in the form Tablet 500 micrograms

substitute:

 

Tablet 500 micrograms

Oral

 

Dexmethsone

AS

MP NP

 

 

30

4

30

 

 

 

 

 

 

 

 

MP NP

 

P14238

60

4

30

 

 

[26]               Schedule 1, Part 1, entry for Dutasteride

substitute:

Dutasteride

Capsule 500 micrograms

Oral

a

APO-Dutasteride

TX

MP NP

C6202 C15018

P6202

30

5

30

 

 

 

 

 

a

Avodart

GK

MP NP

C6202 C15018

P6202

30

5

30

 

 

 

 

 

a

APO-Dutasteride

TX

MP NP

C6202 C15018

P15018

60

5

30

 

 

 

 

 

a

Avodart

GK

MP NP

C6202 C15018

P15018

60

5

30

 

 

[27]               Schedule 1, Part 1, entry for Dutasteride with tamsulosin

substitute:

Dutasteride with tamsulosin

Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms

Oral

a

Doubluts

GC

MP NP

C6189 C15004

P6189

30

5

30

 

 

 

 

 

a

Duodart 500ug/400ug

GK

MP NP

C6189 C15004

P6189

30

5

30

 

 

 

 

 

a

Doubluts

GC

MP NP

C6189 C15004

P15004

60

5

30

 

 

 

 

 

a

Duodart 500ug/400ug

GK

MP NP

C6189 C15004

P15004

60

5

30

 

 

[28]               Schedule 1, Part 1, entry for Empagliflozin

substitute:

Empagliflozin

Tablet 10 mg

Oral

 

Jardiance

BY

MP

C4991 C5629 C7495 C7506 C7528 C12477 C14471 C14859 C14905 C14949 C14974 C14976

P4991 P5629 P7495 P7506 P7528 P12477 P14471

30

5

30

 

 

 

 

 

 

 

 

NP

C4991 C5629 C7495 C7506 C12477 C14471 C14859 C14905 C14949 C14974 C14976

P4991 P5629 P7495 P7506 P12477 P14471

30

5

30

 

 

 

 

 

 

 

 

MP

C4991 C5629 C7495 C7506 C7528 C12477 C14471 C14859 C14905 C14949 C14974 C14976

P14859 P14905 P14949 P14974 P14976

60

5

30

 

 

 

 

 

 

 

 

NP

C4991 C5629 C7495 C7506 C12477 C14471 C14859 C14905 C14949 C14974 C14976

P14859 P14905 P14949 P14974 P14976

60

5

30

 

 

 

Tablet 25 mg

Oral

 

Jardiance

BY

MP

C4991 C5629 C7495 C7506 C7528 C14859 C14905 C14949 C14974

P4991 P5629 P7495 P7506 P7528

30

5

30

 

 

 

 

 

 

 

 

NP

C4991 C5629 C7495 C7506 C14859 C14905 C14949 C14974

P4991 P5629 P7495 P7506

30

5

30

 

 

 

 

 

 

 

 

MP

C4991 C5629 C7495 C7506 C7528 C14859 C14905 C14949 C14974

P14859 P14905 P14949 P14974

60

5

30

 

 

 

 

 

 

 

 

NP

C4991 C5629 C7495 C7506 C14859 C14905 C14949 C14974

P14859 P14905 P14949 P14974

60

5

30

 

 

[29]               Schedule 1, Part 1, entry for Empagliflozin with linagliptin

substitute:

Empagliflozin with linagliptin

Tablet containing 10 mg empagliflozin with 5 mg linagliptin

Oral

 

Glyxambi

BY

MP

C7524 C7556 C14885

P7524 P7556

30

5

30

 

 

 

 

 

 

 

 

NP

C7556 C14885

P7556

30

5

30

 

 

 

 

 

 

 

 

MP

C7524 C7556 C14885

P14885

60

5

30

 

 

 

 

 

 

 

 

NP

C7556 C14885

P14885

60

5

30

 

 

 

Tablet containing 25 mg empagliflozin with 5 mg linagliptin

Oral

 

Glyxambi

BY

MP

C7524 C7556 C14885

P7524 P7556

30

5

30

 

 

 

 

 

 

 

 

NP

C7556 C14885

P7556

30

5

30

 

 

 

 

 

 

 

 

MP

C7524 C7556 C14885

P14885

60

5

30

 

 

 

 

 

 

 

 

NP

C7556 C14885

P14885

60

5

30

 

 

[30]               Schedule 1, Part 1, entry for Empagliflozin with metformin

substitute:

Empagliflozin with metformin

Tablet containing 5 mg empagliflozin with 1 g metformin hydrochloride

Oral

 

Jardiamet 5 mg/1000 mg

BY

MP

C5657 C5798 C5953 C5966 C7492 C7498 C14878 C14881 C14924 C14925

P5657 P5798 P5953 P5966 P7492 P7498

60

5

60

 

 

 

 

 

 

 

 

NP

C5657 C5798 C5966 C7492 C14878 C14881 C14924 C14925

P5657 P5798 P5966 P7492

60

5

60

 

 

 

 

 

 

 

 

MP

C5657 C5798 C5953 C5966 C7492 C7498 C14878 C14881 C14924 C14925

P14878 P14881 P14924 P14925

120

5

60

 

 

 

 

 

 

 

 

NP

C5657 C5798 C5966 C7492 C14878 C14881 C14924 C14925

P14878 P14881 P14924 P14925

120

5

60

 

 

 

Tablet containing 5 mg empagliflozin with 500 mg metformin hydrochloride

Oral

 

Jardiamet 5 mg/500 mg

BY

MP

C5657 C5798 C5953 C5966 C7492 C7498 C14878 C14881 C14924 C14925

P5657 P5798 P5953 P5966 P7492 P7498

60

5

60

 

 

 

 

 

 

 

 

NP

C5657 C5798 C5966 C7492 C14878 C14881 C14924 C14925

P5657 P5798 P5966 P7492

60

5

60

 

 

 

 

 

 

 

 

MP

C5657 C5798 C5953 C5966 C7492 C7498 C14878 C14881 C14924 C14925

P14878 P14881 P14924 P14925

120

5

60

 

 

 

 

 

 

 

 

NP

C5657 C5798 C5966 C7492 C14878 C14881 C14924 C14925

P14878 P14881 P14924 P14925

120

5

60

 

 

 

Tablet containing 12.5 mg empagliflozin with 1 g metformin hydrochloride

Oral

 

Jardiamet 12.5 mg/1000 mg

BY

MP

C5657 C5798 C5953 C5966 C7492 C7498 C14878 C14881 C14924 C14925

P5657 P5798 P5953 P5966 P7492 P7498

60

5

60

 

 

 

 

 

 

 

 

NP

C5657 C5798 C5966 C7492 C14878 C14881 C14924 C14925

P5657 P5798 P5966 P7492

60

5

60

 

 

 

 

 

 

 

 

MP

C5657 C5798 C5953 C5966 C7492 C7498 C14878 C14881 C14924 C14925

P14878 P14881 P14924 P14925

120

5

60

 

 

 

 

 

 

 

 

NP

C5657 C5798 C5966 C7492 C14878 C14881 C14924 C14925

P14878 P14881 P14924 P14925

120

5

60

 

 

 

Tablet containing 12.5 mg empagliflozin with 500 mg metformin hydrochloride

Oral

 

Jardiamet 12.5 mg/500 mg

BY

MP

C5657 C5798 C5953 C5966 C7492 C7498 C14878 C14881 C14924 C14925

P5657 P5798 P5953 P5966 P7492 P7498

60

5

60

 

 

 

 

 

 

 

 

NP

C5657 C5798 C5966 C7492 C14878 C14881 C14924 C14925

P5657 P5798 P5966 P7492

60

5

60

 

 

 

 

 

 

 

 

MP

C5657 C5798 C5953 C5966 C7492 C7498 C14878 C14881 C14924 C14925

P14878 P14881 P14924 P14925

120

5

60

 

 

 

 

 

 

 

 

NP

C5657 C5798 C5966 C7492 C14878 C14881 C14924 C14925

P14878 P14881 P14924 P14925

120

5

60

 

 

[31]               Schedule 1, Part 1, entry for Eprosartan

substitute:


Eprosartan

Tablet 600 mg (as mesilate)

Oral

 

Teveten

GO

MP NP

 

 

28

5

28

 

 

 

 

 

 

 

 

MP NP

 

P6328 P6329 P6332 P6351

28
CN6328 CN6329 CN6332 CN6351

5
CN6328 CN6329 CN6332 CN6351

28

 

 

 

 

 

 

 

 

MP NP

 

P14238

56

5

28

 

 

 

 

 

 

 

 

MP NP

 

P14841 P14969 P14970 P15009

56
CN14841 CN14969 CN14970 CN15009

5
CN14841 CN14969 CN14970 CN15009

28

 

 

[32]               Schedule 1, Part 1, entry for Estradiol in the form Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28

substitute:

 

Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28

Transdermal

 

Sandrena

OX

MP NP

 

 

1

5

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

5

1

 

 

[33]               Schedule 1, Part 1, entry for Estradiol in the form Pessary (modified release) 10 micrograms (as hemihydrate)

substitute:

 

Pessary (modified release) 10 micrograms (as hemihydrate)

Vaginal

a

Estro-Pess

AS

MP NP

 

 

18

2

18

 

 

 

 

 

a

Vagifem Low

NO

MP NP

 

 

18

2

18

 

 

 

 

 

a

Estro-Pess

AS

MP NP

 

P14238

36

2

18

 

 

 

 

 

a

Vagifem Low

NO

MP NP

 

P14238

36

2

18

 

 

[34]               Schedule 1, Part 1, entry for Estradiol in the form Tablet containing estradiol valerate 1 mg

substitute:


 

Tablet containing estradiol valerate 1 mg

Oral

 

Progynova

BN

MP NP

 

 

56

2

56

 

 

 

 

 

 

 

 

MP NP

 

P14238

112

2

56

 

 

[35]               Schedule 1, Part 1, entry for Estradiol in the form Tablet 2 mg

substitute:

 

Tablet 2 mg

Oral

 

Zumenon

GO

MP NP

 

 

56

2

56

 

 

 

 

 

 

 

 

MP NP

 

P14238

112

2

56

 

 

[36]               Schedule 1, Part 1, entry for Estradiol in the form Tablet containing estradiol valerate 2 mg

substitute:

 

Tablet containing estradiol valerate 2 mg

Oral

 

Progynova

BN

MP NP

 

 

56

2

56

 

 

 

 

 

 

 

 

MP NP

 

P14238

112

2

56

 

 

[37]               Schedule 1, Part 1, entry for Estradiol and estradiol with dydrogesterone

substitute:

Estradiol and estradiol with dydrogesterone

Pack containing 14 tablets estradiol 1 mg and 14 tablets estradiol 1 mg with dydrogesterone 10 mg

Oral

 

Femoston 1/10

GO

MP NP

 

 

1

5

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

5

1

 

 

 

Pack containing 14 tablets estradiol 2 mg and 14 tablets estradiol 2 mg with dydrogesterone 10 mg

Oral

 

Femoston 2/10

GO

MP NP

 

 

1

5

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

5

1

 

 

[38]               Schedule 1, Part 1, entry for Estradiol and estradiol with norethisterone

substitute:

Estradiol and estradiol with norethisterone

Pack containing 4 transdermal patches 780 micrograms estradiol (as hemihydrate) and 4 transdermal patches 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate

Transdermal

 

Estalis sequi 50/250

SZ

MP NP

 

 

1

5

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

5

1

 

 

 

Pack containing 4 transdermal patches 780 micrograms estradiol (as hemihydrate) and 4 transdermal patches 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate

Transdermal

 

Estalis sequi 50/140

SZ

MP NP

 

 

1

5

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

5

1

 

 

[39]               Schedule 1, Part 1, entry for Estradiol with norethisterone in the form Transdermal patches containing 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8

substitute:

 

Transdermal patches containing 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8

Transdermal

 

Estalis continuous 50/140

SZ

MP NP

 

 

1

5

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

5

1

 

 

[40]               Schedule 1, Part 1, entry for Estriol

substitute:

Estriol

Vaginal cream 1 mg per g, 15 g

Application

 

Ovestin

AS

MP NP

 

 

1

1

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

1

1

 

 

 

Pessaries 500 micrograms, 15

Vaginal

 

Ovestin Ovula

AS

MP NP

 

 

1

2

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

2

1

 

 

[41]               Schedule 1, Part 1, entry for Ethosuximide in the form Oral solution 250 mg per 5 mL, 200 mL

substitute:

 

Oral solution 250 mg per 5 mL, 200 mL

Oral

 

Zarontin

IX

MP NP

 

 

1

5

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

5

1

 

 

[42]               Schedule 1, Part 1, entry for Everolimus in the form Tablet 0.75 mg

substitute:

 

Tablet 0.75 mg

Oral

a

Certican

NV

MP

 

 

120

3

60

 

 

 

 

 

a

Everocan

CR

MP

 

 

120

3

60

 

 

 

 

 

a

Certican

NV

MP

 

P14238

240

3

60

 

 

 

 

 

a

Everocan

CR

MP

 

P14238

240

3

60

 

 

 

 

 

a

Certican

NV

MP

 

P5554 P5795 P9691 P9693

240
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

60

 

C(100)

 

 

 

a

Everocan

CR

MP

 

P5554 P5795 P9691 P9693

240
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

60

 

C(100)

[43]               Schedule 1, Part 1, entry for Everolimus in the form Tablet 1 mg

substitute:

 

Tablet 1 mg

Oral

a

Certican

NV

MP

 

 

120

3

60

 

 

 

 

 

a

Everocan

CR

MP

 

 

120

3

60

 

 

 

 

 

a

Certican

NV

MP

 

P14238

240

3

60

 

 

 

 

 

a

Everocan

CR

MP

 

P14238

240

3

60

 

 

 

 

 

a

Certican

NV

MP

 

P5554 P5795 P9691 P9693

240
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

60

 

C(100)

 

 

 

a

Everocan

CR

MP

 

P5554 P5795 P9691 P9693

240
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

60

 

C(100)

[44]               Schedule 1, Part 1, entry for Exemestane

substitute:

Exemestane

Tablet 25 mg

Oral

a

APO-Exemestane

TX

MP

C4796 C5522 C14992 C15031

P4796 P5522

30

5

30

 

 

 

 

 

 

 

 

NP

C5522 C14992

P5522

30

5

30

 

 

 

 

 

a

Aromasin

PF

MP

C4796 C5522 C14992 C15031

P4796 P5522

30

5

30

 

 

 

 

 

 

 

 

NP

C5522 C14992

P5522

30

5

30

 

 

 

 

 

a

Exemestane GH

GQ

MP

C4796 C5522 C14992 C15031

P4796 P5522

30

5

30

 

 

 

 

 

 

 

 

NP

C5522 C14992

P5522

30

5

30

 

 

 

 

 

a

Exemestane Sandoz

SZ

MP

C4796 C5522 C14992 C15031

P4796 P5522

30

5

30

 

 

 

 

 

 

 

 

NP

C5522 C14992

P5522

30

5

30

 

 

 

 

 

a

APO-Exemestane

TX

MP

C4796 C5522 C14992 C15031

P14992 P15031

60

5

30

 

 

 

 

 

 

 

 

NP

C5522 C14992

P14992

60

5

30

 

 

 

 

 

a

Aromasin

PF

MP

C4796 C5522 C14992 C15031

P14992 P15031

60

5

30

 

 

 

 

 

 

 

 

NP

C5522 C14992

P14992

60

5

30

 

 

 

 

 

a

Exemestane GH

GQ

MP

C4796 C5522 C14992 C15031

P14992 P15031

60

5

30

 

 

 

 

 

 

 

 

NP

C5522 C14992

P14992

60

5

30

 

 

 

 

 

a

Exemestane Sandoz

SZ

MP

C4796 C5522 C14992 C15031

P14992 P15031

60

5

30

 

 

 

 

 

 

 

 

NP

C5522 C14992

P14992

60

5

30

 

 

[45]               Schedule 1, Part 1, entry for Glibenclamide

substitute:

Glibenclamide

Tablet 5 mg

Oral

 

Daonil

SW

MP NP

 

 

100

5

100

 

 

 

 

 

 

 

 

MP NP

 

P14238

200

5

100

 

 

[46]               Schedule 1, Part 1, entry for Gliclazide in the form Tablet 60 mg (modified release)

substitute:

 

Tablet 60 mg (modified release)

Oral

a

ARDIX GLICLAZIDE 60mg MR

XT

MP NP

 

 

60

5

60

 

 

 

 

 

a

Diamicron 60mg MR

SE

MP NP

 

 

60

5

60

 

 

 

 

 

a

Gliclazide Lupin MR

GQ

MP NP

 

 

60

5

60

 

 

 

 

 

a

Pharmacor Gliclazide MR

CR

MP NP

 

 

60

5

60

 

 

 

 

 

a

ARDIX GLICLAZIDE 60mg MR

XT

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Diamicron 60mg MR

SE

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Gliclazide Lupin MR

GQ

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Pharmacor Gliclazide MR

CR

MP NP

 

P14238

120

5

60

 

 

[47]               Schedule 1, Part 1, entry for Gliclazide in the form Tablet 80 mg (modified release)

substitute:

 

Tablet 80 mg

Oral

a

APO-Gliclazide

TX

MP NP

 

 

100

5

100

 

 

 

 

 

a

APX-Gliclazide

TY

MP NP

 

 

100

5

100

 

 

 

 

 

a

Glyade

AF

MP NP

 

 

100

5

100

 

 

 

 

 

a

Nidem

RW

MP NP

 

 

100

5

100

 

 

 

 

 

a

APO-Gliclazide

TX

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

APX-Gliclazide

TY

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Glyade

AF

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Nidem

RW

MP NP

 

P14238

200

5

100

 

 

[48]               Schedule 1, Part 1, entry for Glimepiride

substitute:

Glimepiride

Tablet 1 mg

Oral

a

Amaryl

SW

MP NP

 

 

30

5

30

 

 

 

 

 

a

Aylide 1

AF

MP NP

 

 

30

5

30

 

 

 

 

 

a

Glimepiride APOTEX

GX

MP NP

 

 

30

5

30

 

 

 

 

 

a

Glimepiride Sandoz

SZ

MP NP

 

 

30

5

30

 

 

 

 

 

a

Amaryl

SW

MP NP

 

P14238

60

5

30

 

 

 

 

 

a

Aylide 1

AF

MP NP

 

P14238

60

5

30

 

 

 

 

 

a

Glimepiride APOTEX

GX

MP NP

 

P14238

60

5

30

 

 

 

 

 

a

Glimepiride Sandoz

SZ

MP NP

 

P14238

60

5

30

 

 

 

Tablet 2 mg

Oral

a

Aylide 2

AF

MP NP

 

 

30

5

30

 

 

 

 

 

a

Glimepiride APOTEX

GX

MP NP

 

 

30

5

30

 

 

 

 

 

a

Glimepiride Sandoz

SZ

MP NP

 

 

30

5

30

 

 

 

 

 

a

Aylide 2

AF

MP NP

 

P14238

60

5

30

 

 

 

 

 

a

Glimepiride APOTEX

GX

MP NP

 

P14238

60

5

30

 

 

 

 

 

a

Glimepiride Sandoz

SZ

MP NP

 

P14238

60

5

30

 

 

 

Tablet 3 mg

Oral

a

Aylide 3

AF

MP NP

 

 

30

5

30

 

 

 

 

 

a

Glimepiride APOTEX

GX

MP NP

 

 

30

5

30

 

 

 

 

 

a

Glimepiride Sandoz

SZ

MP NP

 

 

30

5

30

 

 

 

 

 

a

Aylide 3

AF

MP NP

 

P14238

60

5

30

 

 

 

 

 

a

Glimepiride APOTEX

GX

MP NP

 

P14238

60

5

30

 

 

 

 

 

a

Glimepiride Sandoz

SZ

MP NP

 

P14238

60

5

30

 

 

 

Tablet 4 mg

Oral

a

Aylide 4

AF

MP NP

 

 

30

5

30

 

 

 

 

 

a

Glimepiride APOTEX

GX

MP NP

 

 

30

5

30

 

 

 

 

 

a

Glimepiride Sandoz

SZ

MP NP

 

 

30

5

30

 

 

 

 

 

a

Aylide 4

AF

MP NP

 

P14238

60

5

30

 

 

 

 

 

a

Glimepiride APOTEX

GX

MP NP

 

P14238

60

5

30

 

 

 

 

 

a

Glimepiride Sandoz

SZ

MP NP

 

P14238

60

5

30

 

 

[49]               Schedule 1, Part 1, entry for Glipizide

substitute:

Glipizide

Tablet 5 mg

Oral

a

Melizide

AF

MP NP

 

 

100

5

100

 

 

 

 

 

a

Minidiab

PF

MP NP

 

 

100

5

100

 

 

 

 

 

a

Melizide

AF

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Minidiab

PF

MP NP

 

P14238

200

5

100

 

 

[50]               Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 4 mg

substitute:

Hydrocortisone

Tablet 4 mg

Oral

a

Hydrocortisone Viatris 4

AL

MP NP

 

 

50

4

50

 

 

 

 

 

a

Hysone 4

AF

MP NP

 

 

50

4

50

 

 

 

 

 

a

Hydrocortisone Viatris 4

AL

MP NP

 

P14238

100

4

50

 

 

 

 

 

a

Hysone 4

AF

MP NP

 

P14238

100

4

50

 

 

[51]               Schedule 1, Part 1, entry for Labetalol

substitute:

Labetalol

Tablet containing labetalol hydrochloride 100 mg

Oral

 

Presolol 100

AF

MP NP

 

 

100

5

100

 

 

 

 

 

 

 

 

MP NP

 

P14238

200

5

100

 

 

[52]               Schedule 1, Part 1, entry for Lacosamide

substitute:

Lacosamide

Oral solution 10 mg per mL, 200 mL

Oral

 

Vimpat

UC

MP NP

C8770 C8815 C12092 C14853 C14857

P12092

2

5

1

 

 

 

 

 

 

 

 

MP NP

C8770 C8815 C12092 C14853 C14857

P14853

4

5

1

 

 

 

 

 

 

 

 

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815

6

5

1

 

 

 

 

 

 

 

 

MP NP

C8770 C8815 C12092 C14853 C14857

P14857

12

5

1

 

 

 

Tablet 50 mg

Oral

a

Lacoress

LR

MP NP

C8813

 

14

1

14

 

 

 

 

 

a

Lacosam

AF

MP NP

C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Lacosamide ARX

XT

MP NP

C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Lacosamide Lupin

GQ

MP NP

C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Lacosamide Sandoz

SZ

MP NP

C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Vimcosa

CR

MP NP

C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Vimpat

UC

MP NP

C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Lacosam

AF

MP NP

C8813 C8815 C12092 C14853 C14857

P8815 P12092

56

5

14

 

 

 

 

 

a

Lacosamide ARX

XT

MP NP

C8813 C8815 C12092 C14853 C14857

P8815 P12092

56

5

14

 

 

 

 

 

a

Lacosamide Lupin

GQ

MP NP

C8813 C8815 C12092 C14853 C14857

P8815 P12092

56

5

14

 

 

 

 

 

a

Lacosamide Sandoz

SZ

MP NP

C8813 C8815 C12092 C14853 C14857

P8815 P12092

56

5

14

 

 

 

 

 

a

Vimcosa

CR

MP NP

C8813 C8815 C12092 C14853 C14857

P8815 P12092

56

5

14

 

 

 

 

 

a

Vimpat

UC

MP NP

C8813 C8815 C12092 C14853 C14857

P8815 P12092

56

5

14

 

 

 

 

 

a

Lacosam

AF

MP NP

C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

14

 

 

 

 

 

a

Lacosamide ARX

XT

MP NP

C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

14

 

 

 

 

 

a

Lacosamide Lupin

GQ

MP NP

C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

14

 

 

 

 

 

a

Lacosamide Sandoz

SZ

MP NP

C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

14

 

 

 

 

 

a

Vimcosa

CR

MP NP

C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

14

 

 

 

 

 

a

Vimpat

UC

MP NP

C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

14

 

 

 

Tablet 100 mg

Oral

a

Lacoress

LR

MP NP

C8770 C8813 C8815 C14857

P8813

14

1

14

 

 

 

 

 

a

Lacosamide Sandoz

SZ

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P8813 P12225

14

1

14

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Vimcosa

CR

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P8813 P12225

14

1

14

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Vimpat

UC

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P8813 P12225

14

1

14

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Lacoress

LR

MP NP

C8770 C8813 C8815 C14857

P8770 P8815

56

5

56

 

 

 

 

 

a

Lacosam

AF

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacosamide ARX

XT

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacosamide Lupin

GQ

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacosamide Sandoz

SZ

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Vimcosa

CR

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Vimpat

UC

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacoress

LR

MP NP

C8770 C8813 C8815 C14857

P14857

112

5

56

 

 

 

 

 

a

Lacosam

AF

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Lacosamide ARX

XT

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Lacosamide Lupin

GQ

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Lacosamide Sandoz

SZ

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Vimcosa

CR

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Vimpat

UC

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

Tablet 150 mg

Oral

a

Lacoress

LR

MP NP

C8770 C8813 C8815 C14857

P8813

14

1

14

 

 

 

 

 

a

Vimcosa

CR

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P8813 P12225

14

1

14

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Vimpat

UC

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P8813 P12225

14

1

14

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P8813

14

1

14

 

 

 

 

 

a

Lacoress

LR

MP NP

C8770 C8813 C8815 C14857

P8770 P8815

56

5

56

 

 

 

 

 

a

Lacosam

AF

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacosamide ARX

XT

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacosamide Lupin

GQ

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacosamide Sandoz

SZ

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Vimcosa

CR

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Vimpat

UC

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacoress

LR

MP NP

C8770 C8813 C8815 C14857

P14857

112

5

56

 

 

 

 

 

a

Lacosam

AF

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Lacosamide ARX

XT

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Lacosamide Lupin

GQ

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Lacosamide Sandoz

SZ

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Vimcosa

CR

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Vimpat

UC

MP

C8770 C8813 C8815 C12092 C12225 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

Tablet 200 mg

Oral

a

Lacoress

LR

MP NP

C8770 C8815 C14857

P8770 P8815

56

5

56

 

 

 

 

 

a

Lacosam

AF

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacosamide ARX

XT

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacosamide Lupin

GQ

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacosamide Sandoz

SZ

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Vimcosa

CR

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Vimpat

UC

MP NP

C8770 C8815 C12092 C14853 C14857

P8770 P8815 P12092

56

5

56

 

 

 

 

 

a

Lacoress

LR

MP NP

C8770 C8815 C14857

P14857

112

5

56

 

 

 

 

 

a

Lacosam

AF

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Lacosamide ARX

XT

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Lacosamide Lupin

GQ

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Lacosamide Sandoz

SZ

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Vimcosa

CR

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

 

 

 

a

Vimpat

UC

MP NP

C8770 C8815 C12092 C14853 C14857

P14853 P14857

112

5

56

 

 

[53]               Schedule 1, Part 1, entry for Lamotrigine

substitute:

Lamotrigine

Tablet 5 mg

Oral

 

Lamictal

AS

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

 

 

 

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

Tablet 25 mg

Oral

a

APX-Lamotrigine

TY

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Lamictal

AS

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

LAMITAN

RF

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Lamotrigine GH

GQ

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Logem

AL

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

NOUMED LAMOTRIGINE

VO

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Reedos 25

ZS

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Sandoz Lamotrigine

HX

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

APX-Lamotrigine

TY

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Lamictal

AS

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

LAMITAN

RF

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Lamotrigine GH

GQ

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Logem

AL

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

NOUMED LAMOTRIGINE

VO

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Reedos 25

ZS

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Sandoz Lamotrigine

HX

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

Tablet 50 mg

Oral

a

APX-Lamotrigine

TY

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Lamictal

AS

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

LAMITAN

RF

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Lamotrigine GH

GQ

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Logem

AL

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

NOUMED LAMOTRIGINE

VO

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Reedos 50

ZS

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Sandoz Lamotrigine

HX

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

APX-Lamotrigine

TY

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Lamictal

AS

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

LAMITAN

RF

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Lamotrigine GH

GQ

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Logem

AL

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

NOUMED LAMOTRIGINE

VO

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Reedos 50

ZS

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Sandoz Lamotrigine

HX

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

Tablet 100 mg

Oral

a

APX-Lamotrigine

TY

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Lamictal

AS

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

LAMITAN

RF

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Lamotrigine GH

GQ

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Logem

AL

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

NOUMED LAMOTRIGINE

VO

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Reedos 100

ZS

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Sandoz Lamotrigine

HX

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

APX-Lamotrigine

TY

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Lamictal

AS

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

LAMITAN

RF

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Lamotrigine GH

GQ

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Logem

AL

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

NOUMED LAMOTRIGINE

VO

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Reedos 100

ZS

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Sandoz Lamotrigine

HX

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

Tablet 200 mg

Oral

a

APX-Lamotrigine

TY

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Lamictal

AS

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

LAMITAN

RF

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Lamotrigine GH

GQ

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Logem

AL

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

NOUMED LAMOTRIGINE

VO

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Reedos 200

ZS

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

Sandoz Lamotrigine

HX

MP NP

C11081 C14855

P11081

56

5

56

 

 

 

 

 

a

APX-Lamotrigine

TY

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Lamictal

AS

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

LAMITAN

RF

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Lamotrigine GH

GQ

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Logem

AL

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

NOUMED LAMOTRIGINE

VO

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Reedos 200

ZS

MP NP

C11081 C14855

P14855

112

5

56

 

 

 

 

 

a

Sandoz Lamotrigine

HX

MP NP

C11081 C14855

P14855

112

5

56

 

 

[54]               Schedule 1, Part 1, entry for Lanthanum

substitute:

Lanthanum

Tablet, chewable, 500 mg (as carbonate hydrate)

Oral

 

Fosrenol

TK

MP NP

C5491 C14872

P5491

90

5

90

 

 

 

 

 

 

 

 

MP NP

C5491 C14872

P14872

180

5

90

 

 

 

 

 

 

 

 

MP

C5530 C9762

 

180

5

90

 

C(100)

 

Tablet, chewable, 750 mg (as carbonate hydrate)

Oral

 

Fosrenol

TK

MP NP

C5491 C14872

P5491

90

5

90

 

 

 

 

 

 

 

 

MP NP

C5491 C14872

P14872

180

5

90

 

 

 

 

 

 

 

 

MP

C5530 C9762

 

180

5

90

 

C(100)

 

Tablet, chewable, 1000 mg (as carbonate hydrate)

Oral

 

Fosrenol

TK

MP NP

C5491 C14872

P5491

90

5

90

 

 

 

 

 

 

 

 

MP NP

C5491 C14872

P14872

180

5

90

 

 

 

 

 

 

 

 

MP

C5530 C9762

 

180

5

90

 

C(100)

[55]               Schedule 1, Part 1, entry for Leflunomide

substitute:

Leflunomide

Tablet 10 mg

Oral

a

Arabloc

AV

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Arava

SW

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Ataris 10

AF

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Leflunomide APOTEX

GX

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Leflunomide generichealth

HQ

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Leflunomide Sandoz

SZ

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Lunava 10

RW

MP

C13753 C14942

P13753

30

5

30

 

 

 

 

 

a

Arabloc

AV

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Arava

SW

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Ataris 10

AF

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Leflunomide APOTEX

GX

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Leflunomide generichealth

HQ

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Leflunomide Sandoz

SZ

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Lunava 10

RW

MP

C13753 C14942

P14942

60

5

30

 

 

 

Tablet 20 mg

Oral

a

Arava

SW

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Ataris 20

AF

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Leflunomide APOTEX

GX

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Leflunomide generichealth

HQ

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Leflunomide Sandoz

SZ

MP

C13753 C13771 C14941 C14942

P13753 P13771

30

5

30

 

 

 

 

 

a

Lunava 20

RW

MP

C13753 C14942

P13753

30

5

30

 

 

 

 

 

a

Arava

SW

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Ataris 20

AF

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Leflunomide APOTEX

GX

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Leflunomide generichealth

HQ

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Leflunomide Sandoz

SZ

MP

C13753 C13771 C14941 C14942

P14941 P14942

60

5

30

 

 

 

 

 

a

Lunava 20

RW

MP

C13753 C14942

P14942

60

5

30

 

 

[56]               Schedule 1, Part 1, entry for Letrozole

substitute:

Letrozole

Tablet 2.5 mg

Oral

a

Femara 2.5 mg

NV

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Femolet

AF

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Gynotril

ZS

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Letrozole APOTEX

GX

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Letrozole GH

HQ

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Letrozole Sandoz

SZ

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Pharmacor Letrozole 2.5

CR

MP NP

C5464 C14943

P5464

30

5

30

 

 

 

 

 

a

Femara 2.5 mg

NV

MP NP

C5464 C14943

P14943

60

5

30

 

 

 

 

 

a

Femolet

AF

MP NP

C5464 C14943

P14943

60

5

30

 

 

 

 

 

a

Gynotril

ZS

MP NP

C5464 C14943

P14943

60

5

30

 

 

 

 

 

a

Letrozole APOTEX

GX

MP NP

C5464 C14943

P14943

60

5

30

 

 

 

 

 

a

Letrozole GH

HQ

MP NP

C5464 C14943

P14943

60

5

30

 

 

 

 

 

a

Letrozole Sandoz

SZ

MP NP

C5464 C14943

P14943

60

5

30

 

 

 

 

 

a

Pharmacor Letrozole 2.5

CR

MP NP

C5464 C14943

P14943

60

5

30

 

 

[57]               Schedule 1, Part 1, entry for Levetiracetam

substitute:

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

a

APO-Levetiracetam

TX

MP NP

C11077 C14988

P11077

1

5

1

 

 

 

 

 

a

Keppra

UC

MP NP

C11077 C14988

P11077

1

5

1

 

 

 

 

 

a

Kerron

ZS

MP NP

C11077 C14988

P11077

1

5

1

 

 

 

 

 

a

Levetiracetam GH

GQ

MP NP

C11077 C14988

P11077

1

5

1

 

 

 

 

 

a

Levetiracetam-AFT

AE

MP NP

C11077 C14988

P11077

1

5

1

 

 

 

 

 

a

APO-Levetiracetam

TX

MP NP

C11077 C14988

P14988

2

5

1

 

 

 

 

 

a

Keppra

UC

MP NP

C11077 C14988

P14988

2

5

1

 

 

 

 

 

a

Kerron

ZS

MP NP

C11077 C14988

P14988

2

5

1

 

 

 

 

 

a

Levetiracetam GH

GQ

MP NP

C11077 C14988

P14988

2

5

1

 

 

 

 

 

a

Levetiracetam-AFT

AE

MP NP

C11077 C14988

P14988

2

5

1

 

 

 

Tablet 250 mg

Oral

a

APO-Levetiracetam

TX

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Keppra

UC

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Kevtam 250

AF

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levactam

ZS

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levecetam 250

RZ

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levetiracetam GH

GQ

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levetiracetam Mylan

AL

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levetiracetam SZ

SZ

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levi 250

RW

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

NOUMED LEVETIRACETAM

VO

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

APO-Levetiracetam

TX

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Keppra

UC

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Kevtam 250

AF

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levactam

ZS

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levecetam 250

RZ

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levetiracetam GH

GQ

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levetiracetam Mylan

AL

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levetiracetam SZ

SZ

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levi 250

RW

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

NOUMED LEVETIRACETAM

VO

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

Tablet 500 mg

Oral

a

APO-Levetiracetam

TX

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Keppra

UC

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Kevtam 500

AF

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levactam

ZS

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levecetam 500

RZ

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levetiracetam GH

GQ

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levetiracetam Mylan

AL

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levetiracetam SZ

SZ

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levi 500

RW

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

NOUMED LEVETIRACETAM

VO

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

APO-Levetiracetam

TX

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Keppra

UC

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Kevtam 500

AF

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levactam

ZS

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levecetam 500

RZ

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levetiracetam GH

GQ

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levetiracetam Mylan

AL

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levetiracetam SZ

SZ

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levi 500

RW

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

NOUMED LEVETIRACETAM

VO

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

Tablet 1 g

Oral

a

APO-Levetiracetam

TX

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Keppra

UC

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Kevtam 1000

AF

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levactam

ZS

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levecetam 1000

RZ

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levetiracetam GH

GQ

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levetiracetam Mylan

AL

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levetiracetam SZ

SZ

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

Levi 1000

RW

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

NOUMED LEVETIRACETAM

VO

MP NP

C11116 C14964

P11116

60

5

60

 

 

 

 

 

a

APO-Levetiracetam

TX

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Keppra

UC

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Kevtam 1000

AF

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levactam

ZS

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levecetam 1000

RZ

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levetiracetam GH

GQ

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levetiracetam Mylan

AL

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levetiracetam SZ

SZ

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

Levi 1000

RW

MP NP

C11116 C14964

P14964

120

5

60

 

 

 

 

 

a

NOUMED LEVETIRACETAM

VO

MP NP

C11116 C14964

P14964

120

5

60

 

 

[58]               Schedule 1, Part 1, entry for Linagliptin

substitute:

Linagliptin

Tablet 5 mg

Oral

 

Trajenta

BY

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

30

5

30

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

30

5

30

 

 

 

 

 

 

 

 

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

60

5

30

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

60

5

30

 

 

[59]               Schedule 1, Part 1, entry for Linagliptin with metformin

substitute:

Linagliptin with metformin

Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride

Oral

 

Trajentamet

BY

MP

C6333 C6336 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14935

P6333 P6336 P6344 P6443 P7507 P7530

60

5

60

 

 

 

 

 

 

 

 

NP

C6333 C6336 C6344 C6443 C7530 C14888 C14891 C14894 C14935

P6333 P6336 P6344 P6443 P7530

60

5

60

 

 

 

 

 

 

 

 

MP

C6333 C6336 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14935

P14888 P14891 P14894 P14935

120

5

60

 

 

 

 

 

 

 

 

NP

C6333 C6336 C6344 C6443 C7530 C14888 C14891 C14894 C14935

P14888 P14891 P14894 P14935

120

5

60

 

 

 

Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride

Oral

 

Trajentamet

BY

MP

C6333 C6336 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14935

P6333 P6336 P6344 P6443 P7507 P7530

60

5

60

 

 

 

 

 

 

 

 

NP

C6333 C6336 C6344 C6443 C7530 C14888 C14891 C14894 C14935

P6333 P6336 P6344 P6443 P7530

60

5

60

 

 

 

 

 

 

 

 

MP

C6333 C6336 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14935

P14888 P14891 P14894 P14935

120

5

60

 

 

 

 

 

 

 

 

NP

C6333 C6336 C6344 C6443 C7530 C14888 C14891 C14894 C14935

P14888 P14891 P14894 P14935

120

5

60

 

 

 

Tablet containing 2.5 mg linagliptin with 1000 mg metformin hydrochloride

Oral

 

Trajentamet

BY

MP

C6333 C6336 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14935

P6333 P6336 P6344 P6443 P7507 P7530

60

5

60

 

 

 

 

 

 

 

 

NP

C6333 C6336 C6344 C6443 C7530 C14888 C14891 C14894 C14935

P6333 P6336 P6344 P6443 P7530

60

5

60

 

 

 

 

 

 

 

 

MP

C6333 C6336 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14935

P14888 P14891 P14894 P14935

120

5

60

 

 

 

 

 

 

 

 

NP

C6333 C6336 C6344 C6443 C7530 C14888 C14891 C14894 C14935

P14888 P14891 P14894 P14935

120

5

60

 

 

[60]               Schedule 1, Part 1, entry for Liothyronine

substitute:

Liothyronine

Tablet containing liothyronine sodium 20 micrograms

Oral

 

Tertroxin

AS

MP NP

C6382 C6410 C6475 C14843 C14844 C15038

P6382 P6410 P6475

100

2

100

 

 

 

 

 

 

 

 

MP NP

C6382 C6410 C6475 C14843 C14844 C15038

P14843 P14844 P15038

200

2

100

 

 

[61]               Schedule 1, Part 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 5 mg

substitute:

 

Tablet containing medroxyprogesterone acetate 5 mg

Oral

a

Provera

PF

MP NP

 

 

56

2

56

 

 

 

 

 

a

Ralovera

FZ

MP NP

 

 

56

2

56

 

 

 

 

 

a

Provera

PF

MP NP

 

P14238

112

2

56

 

 

 

 

 

a

Ralovera

FZ

MP NP

 

P14238

112

2

56

 

 

[62]               Schedule 1, Part 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 10 mg

substitute:

 

Tablet containing medroxyprogesterone acetate 10 mg

Oral

a

Provera

PF

MP NP

 

 

30

2

30

 

 

 

 

 

a

Ralovera

FZ

MP NP

 

 

30

2

30

 

 

 

 

 

a

Provera

PF

MP NP

 

P14238

60

2

30

 

 

 

 

 

a

Ralovera

FZ

MP NP

 

P14238

60

2

30

 

 

 

 

 

a

Provera

PF

MP

 

P6244

100

2

100

 

 

 

 

 

a

Ralovera

FZ

MP

 

P6244

100

2

100

 

 

 

 

 

a

Provera

PF

MP

 

P15030

200

2

100

 

 

 

 

 

a

Ralovera

FZ

MP

 

P15030

200

2

100

 

 

[63]               Schedule 1, Part 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 100 mg

substitute:

 

Tablet containing medroxyprogesterone acetate 100 mg

Oral

 

Provera

PF

MP

C5649 C5791 C14965 C14990

P5649 P5791

100

2

100

 

 

 

 

 

 

 

 

MP

C5649 C5791 C14965 C14990

P14965 P14990

200

2

100

 

 

[64]               Schedule 1, Part 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 200 mg

substitute:

 

Tablet containing medroxyprogesterone acetate 200 mg

Oral

 

Provera

PF

MP

C5649 C5791 C14965 C14990

P5649 P5791

60

2

60

 

 

 

 

 

 

 

 

MP

C5649 C5791 C14965 C14990

P14965 P14990

120

2

60

 

 

[65]               Schedule 1, Part 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 250 mg

substitute:

 

Tablet containing medroxyprogesterone acetate 250 mg

Oral

 

Provera

PF

MP

C5649 C5791 C14965 C14990

P5649 P5791

60

2

60

 

 

 

 

 

 

 

 

MP

C5649 C5791 C14965 C14990

P14965 P14990

120

2

60

 

 

[66]               Schedule 1, Part 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 500 mg

substitute:

 

Tablet containing medroxyprogesterone acetate 500 mg

Oral

 

Provera

PF

MP

C5731 C15007

P5731

30

2

30

 

 

 

 

 

 

 

 

MP

C5731 C15007

P15007

60

2

30

 

 

[67]               Schedule 1, Part 1, entry for Metformin

substitute:

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

a

APO-Metformin XR 500

TX

MP NP

 

 

120

5

120

 

 

 

 

 

a

Blooms the Chemist Metformin XR 500

IB

MP NP

 

 

120

5

120

 

 

 

 

 

a

Diabex XR 500

AL

MP NP

 

 

120

5

120

 

 

 

 

 

a

Metex XR

RW

MP NP

 

 

120

5

120

 

 

 

 

 

a

Pharmacor Metformin XR

CR

MP NP

 

 

120

5

120

 

 

 

 

 

a

APO-Metformin XR 500

TX

MP NP

 

P14238

240

5

120

 

 

 

 

 

a

Blooms the Chemist Metformin XR 500

IB

MP NP

 

P14238

240

5

120

 

 

 

 

 

a

Diabex XR 500

AL

MP NP

 

P14238

240

5

120

 

 

 

 

 

a

Metex XR

RW

MP NP

 

P14238

240

5

120

 

 

 

 

 

a

Pharmacor Metformin XR

CR

MP NP

 

P14238

240

5

120

 

 

 

Tablet containing metformin hydrochloride 500 mg

Oral

a

APX-Metformin

TY

MP NP

 

 

100

5

100

 

 

 

 

 

a

Blooms The Chemist Metformin 500 mg

BG

MP NP

 

 

100

5

100

 

 

 

 

 

a

Diabex

AL

MP NP

 

 

100

5

100

 

 

 

 

 

a

Diaformin

AF

MP NP

 

 

100

5

100

 

 

 

 

 

a

FORMET 500

RF

MP NP

 

 

100

5

100

 

 

 

 

 

a

Glucobete 500

ZS

MP NP

 

 

100

5

100

 

 

 

 

 

a

Metformin GH

HQ

MP NP

 

 

100

5

100

 

 

 

 

 

a

Metformin Sandoz

SZ

MP NP

 

 

100

5

100

 

 

 

 

 

a

APX-Metformin

TY

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Blooms The Chemist Metformin 500 mg

BG

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Diabex

AL

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Diaformin

AF

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

FORMET 500

RF

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Glucobete 500

ZS

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Metformin GH

HQ

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Metformin Sandoz

SZ

MP NP

 

P14238

200

5

100

 

 

 

Tablet containing metformin hydrochloride 850 mg

Oral

a

APX-Metformin

TY

MP NP

 

 

60

5

60

 

 

 

 

 

a

Blooms The Chemist Metformin 850 mg

BG

MP NP

 

 

60

5

60

 

 

 

 

 

a

Diabex 850

AL

MP NP

 

 

60

5

60

 

 

 

 

 

a

Diaformin 850

AF

MP NP

 

 

60

5

60

 

 

 

 

 

a

FORMET 850

RF

MP NP

 

 

60

5

60

 

 

 

 

 

a

Glucobete 850

ZS

MP NP

 

 

60

5

60

 

 

 

 

 

a

Metformin Sandoz

SZ

MP NP

 

 

60

5

60

 

 

 

 

 

a

APX-Metformin

TY

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Blooms The Chemist Metformin 850 mg

BG

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Diabex 850

AL

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Diaformin 850

AF

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

FORMET 850

RF

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Glucobete 850

ZS

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Metformin Sandoz

SZ

MP NP

 

P14238

120

5

60

 

 

 

Tablet (extended release) containing metformin hydrochloride 1 g

Oral

a

APO-Metformin XR 1000

TX

MP NP

 

 

60

5

60

 

 

 

 

 

a

Blooms the Chemist Metformin XR 1000

IB

MP NP

 

 

60

5

60

 

 

 

 

 

a

Diabex XR 1000

AL

MP NP

 

 

60

5

60

 

 

 

 

 

a

Diaformin XR 1000

AF

MP NP

 

 

60

5

60

 

 

 

 

 

a

METEX XR

RF

MP NP

 

 

60

5

60

 

 

 

 

 

a

Pharmacor Metformin XR

CR

MP NP

 

 

60

5

60

 

 

 

 

 

a

APO-Metformin XR 1000

TX

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Blooms the Chemist Metformin XR 1000

IB

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Diabex XR 1000

AL

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Diaformin XR 1000

AF

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

METEX XR

RF

MP NP

 

P14238

120

5

60

 

 

 

 

 

a

Pharmacor Metformin XR

CR

MP NP

 

P14238

120

5

60

 

 

 

Tablet containing metformin hydrochloride 1 g

Oral

a

APX-Metformin

TY

MP NP

 

 

90

5

90

 

 

 

 

 

a

Blooms The Chemist Metformin 1000 mg

BG

MP NP

 

 

90

5

90

 

 

 

 

 

a

Diabex 1000

AL

MP NP

 

 

90

5

90

 

 

 

 

 

a

Diaformin 1000

AF

MP NP

 

 

90

5

90

 

 

 

 

 

a

Formet 1000

RW

MP NP

 

 

90

5

90

 

 

 

 

 

a

Glucobete 1000

ZS

MP NP

 

 

90

5

90

 

 

 

 

 

a

Metformin GH

HQ

MP NP

 

 

90

5

90

 

 

 

 

 

a

Metformin Sandoz

SZ

MP NP

 

 

90

5

90

 

 

 

 

 

a

APX-Metformin

TY

MP NP

 

P14238

180

5

90

 

 

 

 

 

a

Blooms The Chemist Metformin 1000 mg

BG

MP NP

 

P14238

180

5

90

 

 

 

 

 

a

Diabex 1000

AL

MP NP

 

P14238

180

5

90

 

 

 

 

 

a

Diaformin 1000

AF

MP NP

 

P14238

180

5

90

 

 

 

 

 

a

Formet 1000

RW

MP NP

 

P14238

180

5

90

 

 

 

 

 

a

Glucobete 1000

ZS

MP NP

 

P14238

180

5

90

 

 

 

 

 

a

Metformin GH

HQ

MP NP

 

P14238

180

5

90

 

 

 

 

 

a

Metformin Sandoz

SZ

MP NP

 

P14238

180

5

90

 

 

[68]               Schedule 1, Part 1, entry for Methenamine

substitute:

Methenamine

Tablet containing methenamine hippurate 1 g

Oral

a

Hiprex

IL

MP NP

 

 

100

5

100

 

 

 

 

 

a

Uramet

AS

MP NP

 

 

100

5

100

 

 

 

 

 

a

Hiprex

IL

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Uramet

AS

MP NP

 

P14238

200

5

100

 

 

[69]               Schedule 1, Part 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial

substitute:

 

Injection 50 mg in 2 mL vial

Injection

 

DBL Methotrexate

PF

MP

 

 

5

5

5

 

 

 

 

 

 

 

 

MP

 

P14238

10

5

5

 

 

 

 

 

 

 

 

MP

 

 

See Note 2

See Note 2

5

 

C(100)

 

 

 

 

 

 

MP

 

P6276

See Note 2

See Note 2

5

 

C(100)

[70]               Schedule 1, Part 1, entry for Minoxidil in the form Tablet 10 mg

substitute:

Minoxidil

Tablet 10 mg

Oral

 

Loniten

PF

MP NP

C5177 C14994

P5177

100

5

100

 

 

 

 

 

 

 

 

MP NP

C5177 C14994

P14994

200

5

100

 

 

[71]               Schedule 1, Part 1, entry for Mycophenolic acid

substitute:

Mycophenolic acid

Capsule containing mycophenolate mofetil 250 mg

Oral

a

Ceptolate

AF

MP

 

 

300

5

50

 

 

 

 

 

a

APO-Mycophenolate

TX

MP

 

 

300

5

100

 

 

 

 

 

a

CellCept

RO

MP

 

 

300

5

100

 

 

 

 

 

a

Mycophenolate Sandoz

SZ

MP

 

 

300

5

100

 

 

 

 

 

a

Pharmacor Mycophenolate 250

CR

MP

 

 

300

5

100

 

 

 

 

 

a

Ceptolate

AF

MP

 

P14238

600

5

50

 

 

 

 

 

 

 

 

MP

 

P5600 P5653 P9689 P9690

600
CN5600 CN5653 CN9689 CN9690

5
CN5600 CN5653 CN9689 CN9690

50

 

C(100)

 

 

 

a

APO-Mycophenolate

TX

MP

 

P14238

600

5

100

 

 

 

 

 

 

 

 

MP

 

P5600 P5653 P9689 P9690

600
CN5600 CN5653 CN9689 CN9690

5
CN5600 CN5653 CN9689 CN9690

100

 

C(100)

 

 

 

a

CellCept

RO

MP

 

P14238

600

5

100

 

 

 

 

 

 

 

 

MP

 

P5600 P5653 P9689 P9690

600
CN5600 CN5653 CN9689 CN9690

5
CN5600 CN5653 CN9689 CN9690

100

 

C(100)

 

 

 

a

Mycophenolate Sandoz

SZ

MP

 

P14238

600

5

100

 

 

 

 

 

 

 

 

MP

 

P5600 P5653 P9689 P9690

600
CN5600 CN5653 CN9689 CN9690

5
CN5600 CN5653 CN9689 CN9690

100

 

C(100)

 

 

 

a

Pharmacor Mycophenolate 250

CR

MP

 

P14238

600

5

100

 

 

 

 

 

 

 

 

MP

 

P5600 P5653 P9689 P9690

600
CN5600 CN5653 CN9689 CN9690

5
CN5600 CN5653 CN9689 CN9690

100

 

C(100)

 

Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL

Oral

a

CellCept

RO

MP

 

 

1

5

1

 

 

 

 

 

a

Pharmacor Mycophenolate

CR

MP

 

 

1

5

1

 

 

 

 

 

a

CellCept

RO

MP

 

P14238

2

5

1

 

 

 

 

 

 

 

 

MP

 

P5554 P5795 P9691 P9693

2
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

1

 

C(100)

 

 

 

a

Pharmacor Mycophenolate

CR

MP

 

P14238

2

5

1

 

 

 

 

 

 

 

 

MP

 

P5554 P5795 P9691 P9693

2
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

1

 

C(100)

 

Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid

Oral

a

Mycophenolic Acid ARX

XT

MP

 

 

120

5

120

 

 

 

 

 

a

Myfortic

NV

MP

 

 

120

5

120

 

 

 

 

 

a

Mycophenolic Acid ARX

XT

MP

 

P14238

240

5

120

 

 

 

 

 

 

 

 

MP

 

P4084 P4095 P9692 P9809

240
CN4084 CN4095 CN9692 CN9809

5
CN4084 CN4095 CN9692 CN9809

120

 

C(100)

 

 

 

a

Myfortic

NV

MP

 

P14238

240

5

120

 

 

 

 

 

 

 

 

MP

 

P4084 P4095 P9692 P9809

240
CN4084 CN4095 CN9692 CN9809

5
CN4084 CN4095 CN9692 CN9809

120

 

C(100)

 

Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid

Oral

a

Mycophenolic Acid ARX

XT

MP

 

 

120

5

120

 

 

 

 

 

a

MYCOTEX

CR

MP

 

 

120

5

120

 

 

 

 

 

a

Myfortic

NV

MP

 

 

120

5

120

 

 

 

 

 

a

Mycophenolic Acid ARX

XT

MP

 

P14238

240

5

120

 

 

 

 

 

 

 

 

MP

 

P4084 P4095 P9692 P9809

240
CN4084 CN4095 CN9692 CN9809

5
CN4084 CN4095 CN9692 CN9809

120

 

C(100)

 

 

 

a

MYCOTEX

CR

MP

 

P14238

240

5

120

 

 

 

 

 

 

 

 

MP

 

P4084 P4095 P9692 P9809

240
CN4084 CN4095 CN9692 CN9809

5
CN4084 CN4095 CN9692 CN9809

120

 

C(100)

 

 

 

a

Myfortic

NV

MP

 

P14238

240

5

120

 

 

 

 

 

 

 

 

MP

 

P4084 P4095 P9692 P9809

240
CN4084 CN4095 CN9692 CN9809

5
CN4084 CN4095 CN9692 CN9809

120

 

C(100)

 

Tablet containing mycophenolate mofetil 500 mg

Oral

a

CellCept

RO

MP

 

 

150

5

50

 

 

 

 

 

a

Ceptolate

AF

MP

 

 

150

5

50

 

 

 

 

 

a

MycoCept

RF

MP

 

 

150

5

50

 

 

 

 

 

a

Mycophenolate APOTEX

GX

MP

 

 

150

5

50

 

 

 

 

 

a

Mycophenolate GH

GQ

MP

 

 

150

5

50

 

 

 

 

 

a

Mycophenolate Sandoz

SZ

MP

 

 

150

5

50

 

 

 

 

 

a

Noumed Mycophenolate

VO

MP

 

 

150

5

50

 

 

 

 

 

a

Pharmacor Mycophenolate 500

CR

MP

 

 

150

5

50

 

 

 

 

 

a

CellCept

RO

MP

 

P14238

300

5

50

 

 

 

 

 

 

 

 

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

Ceptolate

AF

MP

 

P14238

300

5

50

 

 

 

 

 

 

 

 

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

MycoCept

RF

MP

 

P14238

300

5

50

 

 

 

 

 

 

 

 

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

Mycophenolate APOTEX

GX

MP

 

P14238

300

5

50

 

 

 

 

 

 

 

 

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

Mycophenolate GH

GQ

MP

 

P14238

300

5

50

 

 

 

 

 

 

 

 

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

Mycophenolate Sandoz

SZ

MP

 

P14238

300

5

50

 

 

 

 

 

 

 

 

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

Noumed Mycophenolate

VO

MP

 

P14238

300

5

50

 

 

 

 

 

 

 

 

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

Pharmacor Mycophenolate 500

CR

MP

 

P14238

300

5

50

 

 

 

 

 

 

 

 

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

[72]               Schedule 1, Part 1, entry for Norethisterone in the form Tablet 5 mg

substitute:

Norethisterone

Tablet 5 mg

Oral

 

Primolut N

BN

MP NP

 

 

30

2

30

 

 

 

 

 

 

 

 

MP NP

 

P14238

60

2

30

 

 

[73]               Schedule 1, Part 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate)

substitute:

 

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate)

Oral

a

OLMEKAR

RW

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine - MYL 40/5

AF

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine 40/5 APOTEX

TX

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine Sandoz

SZ

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

Pharmacor Olmesartan Amlodipine 40/5

CR

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

Sevikar 40/5

AL

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

OLMEKAR

RW

MP NP

C4373 C14839

P14839

60

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine - MYL 40/5

AF

MP NP

C4373 C14839

P14839

60

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine 40/5 APOTEX

TX

MP NP

C4373 C14839

P14839

60

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine Sandoz

SZ

MP NP

C4373 C14839

P14839

60

5

30

 

 

 

 

 

a

Pharmacor Olmesartan Amlodipine 40/5

CR

MP NP

C4373 C14839

P14839

60

5

30

 

 

 

 

 

a

Sevikar 40/5

AL

MP NP

C4373 C14839

P14839

60

5

30

 

 

[74]               Schedule 1, Part 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate)

substitute:

 

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate)

Oral

a

OLMEKAR

RW

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine - MYL 40/10

AF

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine 40/10 APOTEX

TX

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine Sandoz

SZ

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

Pharmacor Olmesartan Amlodipine 40/10

CR

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

Sevikar 40/10

AL

MP NP

C4373 C14839

P4373

30

5

30

 

 

 

 

 

a

OLMEKAR

RW

MP NP

C4373 C14839

P14839

60

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine - MYL 40/10

AF

MP NP

C4373 C14839

P14839

60

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine 40/10 APOTEX

TX

MP NP

C4373 C14839

P14839

60

5

30

 

 

 

 

 

a

Olmesartan/Amlodipine Sandoz

SZ

MP NP

C4373 C14839

P14839

60

5

30

 

 

 

 

 

a

Pharmacor Olmesartan Amlodipine 40/10

CR

MP NP

C4373 C14839

P14839

60

5

30

 

 

 

 

 

a

Sevikar 40/10

AL

MP NP

C4373 C14839

P14839

60

5

30

 

 

[75]               Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

substitute:

 

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

a

APO-Olmesartan/Amlodipine/HCTZ 40/10/25

TX

MP NP

C4311 C14837

P4311

30

5

30

 

 

 

 

 

a

Olamlo HCT 40/10/25

AL

MP NP

C4311 C14837

P4311

30

5

30

 

 

 

 

 

a

Olmekar HCT 40/10/25

RF

MP NP

C4311 C14837

P4311

30

5

30

 

 

 

 

 

a

Sevikar HCT 40/10/25

AF

MP NP

C4311 C14837

P4311

30

5

30

 

 

 

 

 

a

APO-Olmesartan/Amlodipine/HCTZ 40/10/25

TX

MP NP

C4311 C14837

P14837

60

5

30

 

 

 

 

 

a

Olamlo HCT 40/10/25

AL

MP NP

C4311 C14837

P14837

60

5

30

 

 

 

 

 

a

Olmekar HCT 40/10/25

RF

MP NP

C4311 C14837

P14837

60

5

30

 

 

 

 

 

a

Sevikar HCT 40/10/25

AF

MP NP

C4311 C14837

P14837

60

5

30

 

 

[76]               Schedule 1, Part 1, entry for Oxcarbazepine in the form Oral suspension 60 mg per mL, 250 mL

substitute:

Oxcarbazepine

Oral suspension 60 mg per mL, 250 mL

Oral

 

Trileptal

NV

MP NP

C5183 C14932

P5183

2

5

1

 

 

 

 

 

 

 

 

MP NP

C5183 C14932

P14932

4

5

1

 

 

[77]               Schedule 1, Part 1, entry for Oxcarbazepine in the form Tablet 300 mg

substitute:

 

Tablet 300 mg

Oral

 

Trileptal

NV

MP NP

C5183 C14932

P5183

100

5

100

 

 

 

 

 

 

 

 

MP NP

C5183 C14932

P14932

200

5

100

 

 

[78]               Schedule 1, Part 1, entry for Oxcarbazepine in the form Tablet 600 mg

substitute:

 

Tablet 600 mg

Oral

 

Trileptal

NV

MP NP

C5183 C14932

P5183

100

5

100

 

 

 

 

 

 

 

 

MP NP

C5183 C14932

P14932

200

5

100

 

 

[79]               Schedule 1, Part 1, entry for Oxybutynin

substitute:

Oxybutynin

Transdermal patches 36 mg, 8

Transdermal

 

Oxytrol

TT

MP NP

C6243 C15006

P6243

1

5

1

 

 

 

 

 

 

 

 

MP NP

C6243 C15006

P15006

2

5

1

 

 

 

Tablet containing oxybutynin hydrochloride 5 mg

Oral

 

Ditropan

SW

MP NP

C6241 C14915

P6241

100

5

100

 

 

 

 

 

 

 

 

MP NP

C6241 C14915

P14915

200

5

100

 

 

[80]               Schedule 1, Part 1, entry for Perampanel in the form Tablet 4 mg (as hemisesquihydrate)

substitute:

 

Tablet 4 mg (as hemisesquihydrate)

Oral

 

Fycompa

EI

MP NP

C4658 C7789 C14847 C14852

P7789

28

2

28

 

 

 

 

 

 

 

 

MP NP

C4658 C7789 C14847 C14852

P4658

28

5

28

 

 

 

 

 

 

 

 

MP NP

C4658 C7789 C14847 C14852

P14847

56

2

28

 

 

 

 

 

 

 

 

MP NP

C4658 C7789 C14847 C14852

P14852

56

5

28

 

 

[81]               Schedule 1, Part 1, entry for Perampanel in the form Tablet 6 mg (as hemisesquihydrate)

substitute:

 

Tablet 6 mg (as hemisesquihydrate)

Oral

 

Fycompa

EI

MP NP

C4658 C7789 C14847 C14852

P7789

28

2

28

 

 

 

 

 

 

 

 

MP NP

C4658 C7789 C14847 C14852

P4658

28

5

28

 

 

 

 

 

 

 

 

MP NP

C4658 C7789 C14847 C14852

P14847

56

2

28

 

 

 

 

 

 

 

 

MP NP

C4658 C7789 C14847 C14852

P14852

56

5

28

 

 

[82]               Schedule 1, Part 1, entry for Perampanel in the form Tablet 8 mg (as hemisesquihydrate)

substitute:

 

Tablet 8 mg (as hemisesquihydrate)

Oral

 

Fycompa

EI

MP NP

C4658 C7789 C14847 C14852

P4658 P7789

28

5

28

 

 

 

 

 

 

 

 

MP NP

C4658 C7789 C14847 C14852

P14847 P14852

56

5

28

 

 

[83]               Schedule 1, Part 1, entry for Perampanel in the form Tablet 10 mg (as hemisesquihydrate)

substitute:

 

Tablet 10 mg (as hemisesquihydrate)

Oral

 

Fycompa

EI

MP NP

C4658 C7789 C14847 C14852

P4658 P7789

28

5

28

 

 

 

 

 

 

 

 

MP NP

C4658 C7789 C14847 C14852

P14847 P14852

56

5

28

 

 

[84]               Schedule 1, Part 1, entry for Perampanel in the form Tablet 12 mg (as hemisesquihydrate)

substitute:

 

Tablet 12 mg (as hemisesquihydrate)

Oral

 

Fycompa

EI

MP NP

C4658 C7789 C14847 C14852

P4658 P7789

28

5

28

 

 

 

 

 

 

 

 

MP NP

C4658 C7789 C14847 C14852

P14847 P14852

56

5

28

 

 

[85]               Schedule 1, Part 1, entry for Phenoxymethylpenicillin in the form Capsule 250 mg phenoxymethylpenicillin (as potassium)

substitute:

Phenoxymethylpenicillin

Capsule 250 mg phenoxymethylpenicillin (as potassium)

Oral

 

Cilicaine VK

AF

MP NP PDP

 

 

50

0

50

 

 

 

 

 

 

LPV

IL

MP NP PDP

 

 

50

0

50

 

 

 

 

 

 

Cilicaine VK

AF

MP NP

 

P5697

50

5

50

 

 

 

 

 

 

LPV

IL

MP NP

 

P5697

50

5

50

 

 

 

 

 

 

Cilicaine VK

AF

MP NP

 

P14947

100

5

50

 

 

 

 

 

 

LPV

IL

MP NP

 

P14947

100

5

50

 

 

[86]               Schedule 1, Part 1, entry for Phenoxymethylpenicillin in the form Tablet 250 mg phenoxymethylpenicillin (as potassium)

substitute:


 

Tablet 250 mg phenoxymethylpenicillin (as potassium)

Oral

 

Aspecillin VK

AF

MP NP PDP

 

 

50

0

25

 

 

 

 

 

 

 

 

MP NP

 

P5697

50

5

25

 

 

 

 

 

 

 

 

MP NP

 

P14947

100

5

25

 

 

[87]               Schedule 1, Part 1, entry for Phenytoin

substitute:

Phenytoin

Capsule containing phenytoin sodium 30 mg

Oral

 

Dilantin Sodium

UJ

MP NP

 

 

200

2

200

 

 

 

 

 

 

 

 

MP NP

 

P14238

400

2

200

 

 

 

Capsule containing phenytoin sodium 100 mg

Oral

 

Dilantin Sodium

UJ

MP NP

 

 

200

2

200

 

 

 

 

 

 

 

 

MP NP

 

P14238

400

2

200

 

 

 

Oral suspension 30 mg per 5 mL, 500 mL

Oral

 

Dilantin

UJ

MP NP

 

 

1

3

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

2

3

1

 

 

 

Tablet 50 mg

Oral

 

Dilantin Infatabs

UJ

MP NP

 

 

200

2

200

 

 

 

 

 

 

 

 

MP NP

 

P14238

400

2

200

 

 

[88]               Schedule 1, Part 1, entry for Pioglitazone

substitute:

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

a

Acpio 15

RF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Actaze

RW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Actos

EW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

APOTEX-Pioglitazone

TX

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Vexazone

AF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Acpio 15

RF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Actaze

RW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Actos

EW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

APOTEX-Pioglitazone

TX

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Vexazone

AF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

Tablet 30 mg (as hydrochloride)

Oral

a

Acpio 30

RF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Actaze

RW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Actos

EW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

APOTEX-Pioglitazone

TX

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

NOUMED PIOGLITAZONE

VO

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Pioglitazone Sandoz

SZ

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Vexazone

AF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Acpio 30

RF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Actaze

RW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Actos

EW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

APOTEX-Pioglitazone

TX

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

NOUMED PIOGLITAZONE

VO

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Pioglitazone Sandoz

SZ

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Vexazone

AF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

Tablet 45 mg (as hydrochloride)

Oral

a

Acpio 45

RF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Actaze

RW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Actos

EW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

APOTEX-Pioglitazone

TX

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

NOUMED PIOGLITAZONE

VO

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Pioglitazone Sandoz

SZ

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Vexazone

AF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P4363 P4364 P4388

28

5

28

 

 

 

 

 

a

Acpio 45

RF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Actaze

RW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Actos

EW

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

APOTEX-Pioglitazone

TX

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

NOUMED PIOGLITAZONE

VO

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Pioglitazone Sandoz

SZ

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

 

 

 

a

Vexazone

AF

MP NP

C4363 C4364 C4388 C15001 C15002 C15014

P15001 P15002 P15014

56

5

28

 

 

[89]               Schedule 1, Part 1, entry for Pizotifen

substitute:

Pizotifen

Tablet 500 micrograms (as malate)

Oral

 

Sandomigran 0.5

AE

MP NP

 

 

100

2

100

 

 

 

 

 

 

 

 

MP NP

 

P14238

200

2

100

 

 

[90]               Schedule 1, Part 1, entry for Prednisolone

substitute:

Prednisolone

Suppositories 5 mg (as sodium phosphate), 10

Rectal

 

Predsol

AS

MP NP

C4872 C4893

 

3

3

1

 

 

 

Enema, retention, 20 mg (as sodium phosphate) in 100 mL

Rectal

 

Predsol

AS

MP NP

 

 

28

3

7

 

 

 

Oral solution 5 mg (as sodium phosphate) per mL, 30 mL

Oral

a

PredMix

LN

MP NP

 

 

1

5

1

 

 

 

 

 

a

Redipred

AS

MP NP

 

 

1

5

1

 

 

 

 

 

a

PredMix

LN

MP NP

 

P14238

2

5

1

 

 

 

 

 

a

Redipred

AS

MP NP

 

P14238

2

5

1

 

 

 

Tablet 1 mg

Oral

a

Panafcortelone

AS

MP NP

 

 

100

4

100

 

 

 

 

 

a

Predsolone

LN

MP NP

 

 

100

4

100

 

 

 

 

 

a

Panafcortelone

AS

MP NP

 

P14238

200

4

100

 

 

 

 

 

a

Predsolone

LN

MP NP

 

P14238

200

4

100

 

 

 

Tablet 5 mg

Oral

 

Panafcortelone

AS

MP NP

 

 

60

4

60

 

 

 

 

 

 

Solone

IL

MP NP

 

 

60

4

60

 

 

 

 

 

 

Panafcortelone

AS

MP NP

 

P14238

120

4

60

 

 

 

 

 

 

Solone

IL

MP NP

 

P14238

120

4

60

 

 

 

Tablet 25 mg

Oral

 

Panafcortelone

AS

MP NP

 

 

30

4

30

 

 

 

 

 

 

Solone

IL

MP NP

 

 

30

4

30

 

 

[91]               Schedule 1, Part 1, entry for Prednisone in the form Tablet 1 mg

substitute:

Prednisone

Tablet 1 mg

Oral

a

Panafcort

AS

MP NP

 

 

100

4

100

 

 

 

 

 

a

Predsone

LN

MP NP

 

 

100

4

100

 

 

 

 

 

a

Panafcort

AS

MP NP

 

P14238

200

4

100

 

 

 

 

 

a

Predsone

LN

MP NP

 

P14238

200

4

100

 

 

[92]               Schedule 1, Part 1, entry for Prednisone in the form Tablet 5 mg

substitute:

 

Tablet 5 mg

Oral

 

Panafcort

AS

MP NP

 

 

60

4

60

 

 

 

 

 

 

Sone

IL

MP NP

 

 

60

4

60

 

 

 

 

 

 

Panafcort

AS

MP NP

 

P14238

120

4

60

 

 

 

 

 

 

Sone

IL

MP NP

 

P14238

120

4

60

 

 

[93]               Schedule 1, Part 1, entry for Probenecid

substitute:

Probenecid

Tablet 500 mg

Oral

 

Pro-Cid

FF

MP NP

 

 

100

5

100

 

 

 

 

 

 

 

 

MP NP

 

P14238

200

5

100

 

 

[94]               Schedule 1, Part 1, entry for Propantheline

substitute:

Propantheline

Tablet containing propantheline bromide 15 mg

Oral

 

Pro-Banthine

RW

MP NP

C6241 C14915

P6241

200

5

100

 

 

 

 

 

 

 

 

MP NP

C6241 C14915

P14915

400

5

100

 

 

[95]               Schedule 1, Part 1, entry for Propylthiouracil

substitute:

Propylthiouracil

Tablet 50 mg

Oral

 

PTU

FF

MP NP

 

 

200

2

100

 

 

 

 

 

 

 

 

MP NP

 

P14238

400

2

100

 

 

[96]               Schedule 1, Part 1, entry for Quinagolide

substitute:

Quinagolide

Tablet 75 micrograms (as hydrochloride)

Oral

 

Norprolac

FP

MP

C5136 C5137 C5357 C5398 C14918 C14959 C14983 C15005

P5136 P5137 P5357 P5398

30

5

30

 

 

 

 

 

 

 

 

MP

C5136 C5137 C5357 C5398 C14918 C14959 C14983 C15005

P14918 P14959 P14983 P15005

60

5

30

 

 

[97]               Schedule 1, Part 1, entry for Saxagliptin

substitute:

Saxagliptin

Tablet 2.5 mg (as hydrochloride)

Oral

 

Onglyza

AP

MP

C6346 C6363 C7505 C7541 C14858 C14911 C14954

P6346 P6363 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C7505 C14858 C14911 C14954

P6346 P6363 P7505

28

5

28

 

 

 

 

 

 

 

 

MP

C6346 C6363 C7505 C7541 C14858 C14911 C14954

P14858 P14911 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C7505 C14858 C14911 C14954

P14858 P14911 P14954

56

5

28

 

 

 

Tablet 5 mg (as hydrochloride)

Oral

 

Onglyza

AP

MP

C6346 C6363 C7505 C7541 C14858 C14911 C14954

P6346 P6363 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C7505 C14858 C14911 C14954

P6346 P6363 P7505

28

5

28

 

 

 

 

 

 

 

 

MP

C6346 C6363 C7505 C7541 C14858 C14911 C14954

P14858 P14911 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C7505 C14858 C14911 C14954

P14858 P14911 P14954

56

5

28

 

 

[98]               Schedule 1, Part 1, entry for Saxagliptin with dapagliflozin

substitute:

Saxagliptin with dapagliflozin

Tablet containing saxagliptin 5 mg with dapaglifozin 10 mg

Oral

 

Qtern 5/10

AP

MP

C7524 C7556 C14885

P7524 P7556

28

5

28

 

 

 

 

 

 

 

 

NP

C7556 C14885

P7556

28

5

28

 

 

 

 

 

 

 

 

MP

C7524 C7556 C14885

P14885

56

5

28

 

 

 

 

 

 

 

 

NP

C7556 C14885

P14885

56

5

28

 

 

[99]               Schedule 1, Part 1, entry for Saxagliptin with metformin

substitute:

Saxagliptin with metformin

Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

Oral

 

Kombiglyze XR 2.5/1000

AP

MP

C6333 C6335 C6344 C7507 C7530 C14888 C14891 C14937

P6333 P6335 P6344 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6335 C6344 C7530 C14888 C14891 C14937

P6333 P6335 P6344 P7530

56

5

56

 

 

 

 

 

 

 

 

MP

C6333 C6335 C6344 C7507 C7530 C14888 C14891 C14937

P14888 P14891 P14937

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6335 C6344 C7530 C14888 C14891 C14937

P14888 P14891 P14937

112

5

56

 

 

 

Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 500 mg metformin hydrochloride

Oral

 

Kombiglyze XR 5/500

AP

MP

C6333 C6335 C6344 C7507 C7530 C14888 C14891 C14937

P6333 P6335 P6344 P7507 P7530

28

5

28

 

 

 

 

 

 

 

 

NP

C6333 C6335 C6344 C7530 C14888 C14891 C14937

P6333 P6335 P6344 P7530

28

5

28

 

 

 

 

 

 

 

 

MP

C6333 C6335 C6344 C7507 C7530 C14888 C14891 C14937

P14888 P14891 P14937

56

5

28

 

 

 

 

 

 

 

 

NP

C6333 C6335 C6344 C7530 C14888 C14891 C14937

P14888 P14891 P14937

56

5

28

 

 

 

Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

Oral

 

Kombiglyze XR 5/1000

AP

MP

C6333 C6335 C6344 C7507 C7530 C14888 C14891 C14937

P6333 P6335 P6344 P7507 P7530

28

5

28

 

 

 

 

 

 

 

 

NP

C6333 C6335 C6344 C7530 C14888 C14891 C14937

P6333 P6335 P6344 P7530

28

5

28

 

 

 

 

 

 

 

 

MP

C6333 C6335 C6344 C7507 C7530 C14888 C14891 C14937

P14888 P14891 P14937

56

5

28

 

 

 

 

 

 

 

 

NP

C6333 C6335 C6344 C7530 C14888 C14891 C14937

P14888 P14891 P14937

56

5

28

 

 

[100]           Schedule 1, Part 1, entry for Sevelamer

substitute:

Sevelamer

Tablet containing sevelamer carbonate 800 mg

Oral

 

Sevelamer Apotex

TX

MP NP

C5491 C14984

P5491

180

5

180

 

 

 

 

 

 

Sevelamer Lupin

GQ

MP NP

C5491 C14984

P5491

180

5

180

 

 

 

 

 

 

Sevelamer Apotex

TX

MP NP

C5491 C14984

P14984

360

5

180

 

 

 

 

 

 

 

 

MP

C5530 C9762

 

360

5

180

 

C(100)

 

 

 

 

Sevelamer Lupin

GQ

MP NP

C5491 C14984

P14984

360

5

180

 

 

 

 

 

 

 

 

MP

C5530 C9762

 

360

5

180

 

C(100)

 

Tablet containing sevelamer hydrochloride 800 mg

Oral

 

Renagel

GZ

MP NP

C5491 C14984

P5491

180

5

180

 

 

 

 

 

 

 

 

MP NP

C5491 C14984

P14984

360

5

180

 

 

 

 

 

 

 

 

MP

C5530 C9762

 

360

5

180

 

C(100)

[101]           Schedule 1, Part 1, entry for Sirolimus

substitute:

Sirolimus

Oral solution 1 mg per mL, 60 mL

Oral

 

Rapamune

PF

MP

 

 

1

3

1

 

 

 

 

 

 

 

 

MP

 

P14238

2

3

1

 

 

 

 

 

 

 

 

MP

 

P5795 P9914

2
CN5795 CN9914

5
CN5795 CN9914

1

 

C(100)

 

Tablet 0.5 mg

Oral

 

Rapamune

PF

MP

 

 

100

3

100

 

 

 

 

 

 

 

 

MP

 

P14238

200

3

100

 

 

 

 

 

 

 

 

MP

 

P5795 P9914

200
CN5795 CN9914

5
CN5795 CN9914

100

 

C(100)

 

Tablet 1 mg

Oral

 

Rapamune

PF

MP

 

 

100

3

100

 

 

 

 

 

 

 

 

MP

 

P14238

200

3

100

 

 

 

 

 

 

 

 

MP

 

P5795 P9914

200
CN5795 CN9914

5
CN5795 CN9914

100

 

C(100)

 

Tablet 2 mg

Oral

 

Rapamune

PF

MP

 

 

100

3

100

 

 

 

 

 

 

 

 

MP

 

P14238

200

3

100

 

 

 

 

 

 

 

 

MP

 

P5795 P9914

200
CN5795 CN9914

5
CN5795 CN9914

100

 

C(100)

[102]           Schedule 1, Part 1, entry for Sitagliptin

substitute:

Sitagliptin

Tablet 25 mg

Oral

a

Januvia

XW

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitagliptin Lupin

GQ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitagliptin Sandoz Pharma

SZ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitagliptin SUN

RA

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitaglo

CR

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Xelevia

XT

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Januvia

XW

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitagliptin Lupin

GQ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitagliptin Sandoz Pharma

SZ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitagliptin SUN

RA

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitaglo

CR

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Xelevia

XT

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

Tablet 50 mg

Oral

a

Januvia

XW

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitagliptin Lupin

GQ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitagliptin Sandoz Pharma

SZ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitagliptin SUN

RA

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitaglo

CR

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Xelevia

XT

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Januvia

XW

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitagliptin Lupin

GQ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitagliptin Sandoz Pharma

SZ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitagliptin SUN

RA

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitaglo

CR

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Xelevia

XT

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

Tablet 100 mg

Oral

a

Januvia

XW

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitagliptin Lupin

GQ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitagliptin Sandoz Pharma

SZ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitagliptin SUN

RA

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Sitaglo

CR

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Xelevia

XT

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505 P7541

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P6346 P6363 P6376 P7505

28

5

28

 

 

 

 

 

a

Januvia

XW

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitagliptin Lupin

GQ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitagliptin Sandoz Pharma

SZ

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitagliptin SUN

RA

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Sitaglo

CR

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

a

Xelevia

XT

MP

C6346 C6363 C6376 C7505 C7541 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505 C14858 C14911 C14950 C14954

P14858 P14911 P14950 P14954

56

5

28

 

 

[103]           Schedule 1, Part 1, entry for Sitagliptin with metformin

substitute:

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

a

Janumet

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

SITAGLIPTIN/METFORMIN 50/500 SUN

RA

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Sitagliptin/Metformin Sandoz

SZ

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Velmetia

XT

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Janumet

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

a

SITAGLIPTIN/METFORMIN 50/500 SUN

RA

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

a

Sitagliptin/Metformin Sandoz

SZ

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

a

Velmetia

XT

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

a

Janumet

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

SITAGLIPTIN/METFORMIN 50/850 SUN

RA

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Sitagliptin/Metformin Sandoz

SZ

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Velmetia

XT

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Janumet

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

a

SITAGLIPTIN/METFORMIN 50/850 SUN

RA

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

a

Sitagliptin/Metformin Sandoz

SZ

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

a

Velmetia

XT

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

a

Janumet XR

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Sitagliptin/Metformin Sandoz XR

SZ

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Janumet XR

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

a

Sitagliptin/Metformin Sandoz XR

SZ

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

a

Janumet

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

SITAGLIPTIN/METFORMIN 50/1000 SUN

RA

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Sitagliptin/Metformin Sandoz

SZ

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Velmetia

XT

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

56

5

56

 

 

 

 

 

a

Janumet

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

a

SITAGLIPTIN/METFORMIN 50/1000 SUN

RA

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

a

Sitagliptin/Metformin Sandoz

SZ

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

a

Velmetia

XT

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

112

5

56

 

 

 

Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

a

Janumet XR

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

28

5

28

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

28

5

28

 

 

 

 

 

a

Sitagliptin/Metformin Sandoz XR

SZ

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7507 P7530

28

5

28

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P6333 P6334 P6344 P6443 P7530

28

5

28

 

 

 

 

 

a

Janumet XR

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

56

5

28

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

56

5

28

 

 

 

 

 

a

Sitagliptin/Metformin Sandoz XR

SZ

MP

C6333 C6334 C6344 C6443 C7507 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

56

5

28

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530 C14888 C14891 C14894 C14933

P14888 P14891 P14894 P14933

56

5

28

 

 

[104]           Schedule 1, Part 1, entry for Sodium acid phosphate

substitute:

Sodium acid phosphate

Tablet, compound effervescent, equivalent to 500 mg phosphorus

Oral

 

PHOSPHATE PHEBRA

FG

MP NP

C5089 C5095 C5114 C5123 C14874 C14921 C14922 C14962

P5089 P5095 P5114 P5123

100

5

100

 

 

 

 

 

 

 

 

MP NP

C5089 C5095 C5114 C5123 C14874 C14921 C14922 C14962

P14874 P14921 P14922 P14962

200

5

100

 

 

[105]           Schedule 1, Part 1, entry for Sodium bicarbonate

substitute:

Sodium bicarbonate

Capsule 840 mg

Oral

 

Sodibic

AS

MP NP

 

 

100

2

100

 

 

 

 

 

 

 

 

MP NP

 

P14238

200

2

100

 

 

[106]           Schedule 1, Part 1, entry for Spironolactone in the form Tablet 100 mg

substitute:

 

Tablet 100 mg

Oral

a

Aldactone

PF

MP NP

 

 

100

5

100

 

 

 

 

 

a

Spiractin 100

AF

MP NP

 

 

100

5

100

 

 

 

 

 

a

Spironolactone Viatris 100

AL

MP NP

 

 

100

5

100

 

 

 

 

 

a

Aldactone

PF

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Spiractin 100

AF

MP NP

 

P14238

200

5

100

 

 

 

 

 

a

Spironolactone Viatris 100

AL

MP NP

 

P14238

200

5

100

 

 

[107]           Schedule 1, Part 1, entry for Sucroferric oxyhydroxide

substitute:

Sucroferric oxyhydroxide

Tablet, chewable, 2.5 g (equivalent to 500 mg iron)

Oral

 

Velphoro

VL

MP NP

C5491 C14872

P5491

90

5

90

 

 

 

 

 

 

 

 

MP NP

C5491 C14872

P14872

180

5

90

 

 

 

 

 

 

 

 

MP

C5530 C9762

 

180

5

90

 

C(100)

[108]           Schedule 1, Part 1, entry for Sulthiame

substitute:

Sulthiame

Tablet 50 mg

Oral

 

Ospolot

FF

MP NP

 

 

200

2

200

 

 

 

 

 

 

 

 

MP NP

 

P14238

400

2

200

 

 

 

Tablet 200 mg

Oral

 

Ospolot

FF

MP NP

 

 

200

2

200

 

 

 

 

 

 

 

 

MP NP

 

P14238

400

2

200

 

 

[109]           Schedule 1, Part 1, entry for Tacrolimus

substitute:

Tacrolimus

Capsule 0.5 mg

Oral

a

Pacrolim

AF

MP

 

 

100

3

100

 

 

 

 

 

a

Pharmacor Tacrolimus 0.5

CR

MP

 

 

100

3

100

 

 

 

 

 

a

Prograf

LL

MP

 

 

100

3

100

 

 

 

 

 

a

Tacrograf

RW

MP

 

 

100

3

100

 

 

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

 

100

3

100

 

 

 

 

 

a

Pacrolim

AF

MP

 

P14238

200

3

100

 

 

 

 

 

a

Pharmacor Tacrolimus 0.5

CR

MP

 

P14238

200

3

100

 

 

 

 

 

a

Prograf

LL

MP

 

P14238

200

3

100

 

 

 

 

 

a

Tacrograf

RW

MP

 

P14238

200

3

100

 

 

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

P14238

200

3

100

 

 

 

 

 

a

Pacrolim

AF

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Pharmacor Tacrolimus 0.5

CR

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Prograf

LL

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Tacrograf

RW

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

Capsule 0.5 mg (once daily prolonged release)

Oral

 

ADVAGRAF XL

LQ

MP

 

 

30

3

30

 

 

 

 

 

 

 

 

MP

 

P14238

60

3

30

 

 

 

 

 

 

 

 

MP

 

P5569 P9697

60
CN5569 CN9697

5
CN5569 CN9697

30

 

C(100)

 

Capsule 0.75 mg

Oral

 

Tacrolimus Sandoz

SZ

MP

 

 

100

3

100

 

 

 

 

 

 

 

 

MP

 

P14238

200

3

100

 

 

 

 

 

 

 

 

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

Capsule 1 mg

Oral

a

Pacrolim

AF

MP

 

 

100

3

100

 

 

 

 

 

a

Pharmacor Tacrolimus 1

CR

MP

 

 

100

3

100

 

 

 

 

 

a

Prograf

LL

MP

 

 

100

3

100

 

 

 

 

 

a

Tacrograf

RW

MP

 

 

100

3

100

 

 

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

 

100

3

100

 

 

 

 

 

a

Pacrolim

AF

MP

 

P14238

200

3

100

 

 

 

 

 

a

Pharmacor Tacrolimus 1

CR

MP

 

P14238

200

3

100

 

 

 

 

 

a

Prograf

LL

MP

 

P14238

200

3

100

 

 

 

 

 

a

Tacrograf

RW

MP

 

P14238

200

3

100

 

 

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

P14238

200

3

100

 

 

 

 

 

a

Pacrolim

AF

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Pharmacor Tacrolimus 1

CR

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Prograf

LL

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Tacrograf

RW

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

Capsule 1 mg (once daily prolonged release)

Oral

 

ADVAGRAF XL

LQ

MP

 

 

60

3

60

 

 

 

 

 

 

 

 

MP

 

P14238

120

3

60

 

 

 

 

 

 

 

 

MP

 

P5569 P9697

120
CN5569 CN9697

5
CN5569 CN9697

60

 

C(100)

 

Capsule 2 mg

Oral

 

Tacrolimus Sandoz

SZ

MP

 

 

100

3

100

 

 

 

 

 

 

 

 

MP

 

P14238

200

3

100

 

 

 

 

 

 

 

 

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

Capsule 3 mg (once daily prolonged release)

Oral

 

ADVAGRAF XL

LQ

MP

 

 

50

2

50

 

 

 

 

 

 

 

 

MP

 

P14238

100

2

50

 

 

 

 

 

 

 

 

MP

 

P5569 P9697

100
CN5569 CN9697

3
CN5569 CN9697

50

 

C(100)

 

Capsule 5 mg

Oral

a

Pharmacor Tacrolimus 5

CR

MP

 

 

50

3

50

 

 

 

 

 

a

Prograf

LL

MP

 

 

50

3

50

 

 

 

 

 

a

Tacrograf

RW

MP

 

 

50

3

50

 

 

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

 

50

3

50

 

 

 

 

 

a

Pharmacor Tacrolimus 5

CR

MP

 

P14238

100

3

50

 

 

 

 

 

a

Prograf

LL

MP

 

P14238

100

3

50

 

 

 

 

 

a

Tacrograf

RW

MP

 

P14238

100

3

50

 

 

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

P14238

100

3

50

 

 

 

 

 

a

Pharmacor Tacrolimus 5

CR

MP

 

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

50

 

C(100)

 

 

 

a

Prograf

LL

MP

 

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

50

 

C(100)

 

 

 

a

Tacrograf

RW

MP

 

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

50

 

C(100)

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

50

 

C(100)

 

Capsule 5 mg (once daily prolonged release)

Oral

 

ADVAGRAF XL

LQ

MP

 

 

30

3

30

 

 

 

 

 

 

 

 

MP

 

P14238

60

3

30

 

 

 

 

 

 

 

 

MP

 

P5569 P9697

60
CN5569 CN9697

5
CN5569 CN9697

30

 

C(100)

[110]           Schedule 1, Part 1, entry for Tamoxifen

substitute:

Tamoxifen

Tablet 20 mg (as citrate)

Oral

a

Genox 20

AF

MP NP

C6381 C6421 C14895 C14989

P6421

30

5

30

 

 

 

 

 

a

Nolvadex-D

AP

MP NP

C6421 C6449 C14895 C14989

P6421

30

5

30

 

 

 

 

 

a

Genox 20

AF

MP NP

C6381 C6421 C14895 C14989

P14989

60

5

30

 

 

 

 

 

 

 

 

MP NP

C6381 C6421 C14895 C14989

P6381

60

5

60

 

 

 

 

 

a

Nolvadex-D

AP

MP NP

C6421 C6449 C14895 C14989

P6449 P14989

60

5

30

 

 

 

 

 

a

GenRx Tamoxifen

GX

MP NP

C6381 C14895

P6381

60

5

60

 

 

 

 

 

a

Tamosin

OX

MP NP

C6381 C14895

P6381

60

5

60

 

 

 

 

 

a

Tamoxifen Sandoz

SZ

MP NP

C6381 C14895

P6381

60

5

60

 

 

 

 

 

a

Nolvadex-D

AP

MP NP

C6421 C6449 C14895 C14989

P14895

120

5

30

 

 

 

 

 

a

Genox 20

AF

MP NP

C6381 C6421 C14895 C14989

P14895

120

5

60

 

 

 

 

 

a

GenRx Tamoxifen

GX

MP NP

C6381 C14895

P14895

120

5

60

 

 

 

 

 

a

Tamosin

OX

MP NP

C6381 C14895

P14895

120

5

60

 

 

 

 

 

a

Tamoxifen Sandoz

SZ

MP NP

C6381 C14895

P14895

120

5

60

 

 

[111]           Schedule 1, Part 1, entry for Teriparatide

substitute:

Teriparatide

Injection 250 micrograms per mL, 2.4 mL in multi-dose pre‑filled cartridge

Injection

 

Terrosa

FX

MP

C12270 C12492 C14997

P12270 P12492

1

5

1

 

 

 

 

 

 

 

 

MP

C12270 C12492 C14997

P14997

2

5

1

 

 

[112]           Schedule 1, Part 1, entry for Testosterone in the form Transdermal gel (pump pack) 12.5 mg per 1.25 g dose, 60 doses, 2

substitute:

 

Transdermal gel (pump pack) 12.5 mg per 1.25 g dose, 60 doses, 2

Transdermal

 

Testogel

HB

MP

C6324 C6910 C6919 C6933 C6934 C14912 C14913 C14955 C14956 C15015

P6324 P6910 P6919 P6933 P6934

1

4

1

 

 

 

 

 

 

 

 

MP

C6324 C6910 C6919 C6933 C6934 C14912 C14913 C14955 C14956 C15015

P14912 P14913 P14955 P14956 P15015

2

4

1

 

 

[113]           Schedule 1, Part 1, entry for Testosterone in the form Transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses

substitute:

 

Transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses

Transdermal

 

Testavan

IX

MP

C6324 C6910 C6919 C6933 C6934 C14912 C14913 C14955 C14956 C15015

P6324 P6910 P6919 P6933 P6934

1

5

1

 

 

 

 

 

 

 

 

MP

C6324 C6910 C6919 C6933 C6934 C14912 C14913 C14955 C14956 C15015

P14912 P14913 P14955 P14956 P15015

2

5

1

 

 

[114]           Schedule 1, Part 1, entry for Testosterone in the form Transdermal gel 50 mg in 5 g sachet, 30

substitute:

 

Transdermal gel 50 mg in 5 g sachet, 30

Transdermal

 

Testogel

HB

MP

C6324 C6910 C6919 C6933 C6934 C14912 C14913 C14955 C14956 C15015

P6324 P6910 P6919 P6933 P6934

1

5

1

 

 

 

 

 

 

 

 

MP

C6324 C6910 C6919 C6933 C6934 C14912 C14913 C14955 C14956 C15015

P14912 P14913 P14955 P14956 P15015

2

5

1

 

 

[115]           Schedule 1, Part 1, entry for Tiagabine

substitute:

Tiagabine

Tablet 5 mg (as hydrochloride)

Oral

 

Gabitril

TB

MP NP

C4928 C14883

P4928

100

5

50

 

 

 

 

 

 

 

 

MP NP

C4928 C14883

P14883

200

5

50

 

 

 

Tablet 10 mg (as hydrochloride)

Oral

 

Gabitril

TB

MP NP

C4928 C14883

P4928

100

5

50

 

 

 

 

 

 

 

 

MP NP

C4928 C14883

P14883

200

5

50

 

 

 

Tablet 15 mg (as hydrochloride)

Oral

 

Gabitril

TB

MP NP

C4928 C14883

P4928

100

5

50

 

 

 

 

 

 

 

 

MP NP

C4928 C14883

P14883

200

5

50

 

 

[116]           Schedule 1, Part 1, entry for Tobramycin in the form Capsule containing powder for oral inhalation 28 mg (for use in podhaler)

substitute:

Tobramycin

Capsule containing powder for oral inhalation 28 mg (for use in podhaler)

Inhalation by mouth

 

TOBI podhaler

GO

MP

C4456 C4513 C15036

P4456

224

0

224

 

 

 

 

 

 

 

 

MP

C4456 C4513 C15036

P4513

224

2

224

 

 

 

 

 

 

 

 

MP

C4456 C4513 C15036

P15036

448

2

224

 

 

[117]           Schedule 1, Part 1, entry for Tobramycin in the form Solution for inhalation 300 mg in 5 mL

substitute:

 

Solution for inhalation 300 mg in 5 mL

Inhalation

a

Tobi

GO

MP

C5520 C15040

P5520

56

2

56

 

 

 

 

 

a

TOBRAMYCIN SUN

RA

MP

C5520 C15040

P5520

56

2

56

 

 

 

 

 

a

Tobramycin WKT

LI

MP

C5520 C15040

P5520

56

2

56

 

 

 

 

 

a

Tobi

GO

MP

C5520 C15040

P15040

112

2

56

 

 

 

 

 

a

TOBRAMYCIN SUN

RA

MP

C5520 C15040

P15040

112

2

56

 

 

 

 

 

a

Tobramycin WKT

LI

MP

C5520 C15040

P15040

112

2

56

 

 

[118]           Schedule 1, Part 1, entry for Topiramate

substitute:

Topiramate

Capsule 15 mg

Oral

 

Topamax Sprinkle

JC

MP NP

C5173 C14931

P5173

60

5

60

 

 

 

 

 

 

 

 

MP NP

C5173 C14931

P14931

120

5

60

 

 

 

Capsule 25 mg

Oral

 

Topamax Sprinkle

JC

MP NP

C5173 C14931

P5173

60

5

60

 

 

 

 

 

 

 

 

MP NP

C5173 C14931

P14931

120

5

60

 

 

 

Capsule 50 mg

Oral

 

Topamax Sprinkle

JC

MP NP

C5173 C14931

P5173

60

5

60

 

 

 

 

 

 

 

 

MP NP

C5173 C14931

P14931

120

5

60

 

 

 

Tablet 25 mg

Oral

a

APO-Topiramate

TX

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Epiramax 25

RW

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

NOUMED TOPIRAMATE

VO

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

RBX Topiramate

RA

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Tamate

AF

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Topamax

JC

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Topiramate Sandoz

SZ

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

APO-Topiramate

TX

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Epiramax 25

RW

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

NOUMED TOPIRAMATE

VO

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

RBX Topiramate

RA

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Tamate

AF

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Topamax

JC

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Topiramate Sandoz

SZ

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

Tablet 50 mg

Oral

a

APO-Topiramate

TX

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Epiramax 50

RW

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

NOUMED TOPIRAMATE

VO

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

RBX Topiramate

RA

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Tamate

AF

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Topamax

JC

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Topiramate Sandoz

SZ

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

APO-Topiramate

TX

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Epiramax 50

RW

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

NOUMED TOPIRAMATE

VO

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

RBX Topiramate

RA

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Tamate

AF

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Topamax

JC

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Topiramate Sandoz

SZ

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

Tablet 100 mg

Oral

a

APO-Topiramate

TX

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Epiramax 100

RW

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

NOUMED TOPIRAMATE

VO

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

RBX Topiramate

RA

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Tamate

AF

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Topamax

JC

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

Topiramate Sandoz

SZ

MP NP

C5325 C5516 C14901 C14973

P5325 P5516

60

5

60

 

 

 

 

 

a

APO-Topiramate

TX

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Epiramax 100

RW

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

NOUMED TOPIRAMATE

VO

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

RBX Topiramate

RA

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Tamate

AF

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Topamax

JC

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

 

 

a

Topiramate Sandoz

SZ

MP NP

C5325 C5516 C14901 C14973

P14901 P14973

120

5

60

 

 

 

Tablet 200 mg

Oral

a

APO-Topiramate

TX

MP NP

C5516 C14973

P5516

60

5

60

 

 

 

 

 

a

Epiramax 200

RW

MP NP

C5516 C14973

P5516

60

5

60

 

 

 

 

 

a

NOUMED TOPIRAMATE

VO

MP NP

C5516 C14973

P5516

60

5

60

 

 

 

 

 

a

RBX Topiramate

RA

MP NP

C5516 C14973

P5516

60

5

60

 

 

 

 

 

a

Tamate

AF

MP NP

C5516 C14973

P5516

60

5

60

 

 

 

 

 

a

Topamax

JC

MP NP

C5516 C14973

P5516

60

5

60

 

 

 

 

 

a

Topiramate Sandoz

SZ

MP NP

C5516 C14973

P5516

60

5

60

 

 

 

 

 

a

APO-Topiramate

TX

MP NP

C5516 C14973

P14973

120

5

60

 

 

 

 

 

a

Epiramax 200

RW

MP NP

C5516 C14973

P14973

120

5

60

 

 

 

 

 

a

NOUMED TOPIRAMATE

VO

MP NP

C5516 C14973

P14973

120

5

60

 

 

 

 

 

a

RBX Topiramate

RA

MP NP

C5516 C14973

P14973

120

5

60

 

 

 

 

 

a

Tamate

AF

MP NP

C5516 C14973

P14973

120

5

60

 

 

 

 

 

a

Topamax

JC

MP NP

C5516 C14973

P14973

120

5

60

 

 

 

 

 

a

Topiramate Sandoz

SZ

MP NP

C5516 C14973

P14973

120

5

60

 

 

[119]           Schedule 1, Part 1, entry for Toremifene

substitute:

Toremifene

Tablet 60 mg (as citrate)

Oral

 

Fareston

OX

MP

 

 

30

5

30

 

 

 

 

 

 

 

 

MP

 

P14238

60

5

30

 

 

[120]           Schedule 1, Part 1, entry for Valproic acid

substitute:

Valproic acid

Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL

Oral

 

Epilim Liquid

SW

MP NP

 

 

2

2

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

4

2

1

 

 

 

Oral solution containing sodium valproate 200 mg per 5 mL, 300 mL

Oral

 

Epilim Syrup

SW

MP NP

 

 

2

2

1

 

 

 

 

 

 

 

 

MP NP

 

P14238

4

2

1

 

 

 

Tablet, crushable, containing sodium valproate 100 mg

Oral

 

Epilim

SW

MP NP

 

 

200

2

100

 

 

 

 

 

 

 

 

MP NP

 

P14238

400

2

100

 

 

 

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

a

Epilim EC

SW

MP NP

 

 

200

2

100

 

 

 

 

 

a

Sodium Valproate Sandoz

SZ

MP NP

 

 

200

2

100

 

 

 

 

 

a

Valprease 200

RW

MP NP

 

 

200

2

100

 

 

 

 

 

a

Valpro EC 200

AF

MP NP

 

 

200

2

100

 

 

 

 

 

a

Valproate Winthrop EC 200

WA

MP NP

 

 

200

2

100

 

 

 

 

 

a

Epilim EC

SW

MP NP

 

P14238

400

2

100

 

 

 

 

 

a

Sodium Valproate Sandoz

SZ

MP NP

 

P14238

400

2

100

 

 

 

 

 

a

Valprease 200

RW

MP NP

 

P14238

400

2

100

 

 

 

 

 

a

Valpro EC 200

AF

MP NP

 

P14238

400

2

100

 

 

 

 

 

a

Valproate Winthrop EC 200

WA

MP NP

 

P14238

400

2

100

 

 

 

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

a

Epilim EC

SW

MP NP

 

 

200

2

100

 

 

 

 

 

a

Sodium Valproate Sandoz

SZ

MP NP

 

 

200

2

100

 

 

 

 

 

a

Valprease 500

RW

MP NP

 

 

200

2

100

 

 

 

 

 

a

Valpro EC 500

AF

MP NP

 

 

200

2

100

 

 

 

 

 

a

Valproate Winthrop EC 500

WA

MP NP

 

 

200

2

100

 

 

 

 

 

a

Epilim EC

SW

MP NP

 

P14238

400

2

100

 

 

 

 

 

a

Sodium Valproate Sandoz

SZ

MP NP

 

P14238

400

2

100

 

 

 

 

 

a

Valprease 500

RW

MP NP

 

P14238

400

2

100

 

 

 

 

 

a

Valpro EC 500

AF

MP NP

 

P14238

400

2

100

 

 

 

 

 

a

Valproate Winthrop EC 500

WA

MP NP

 

P14238

400

2

100

 

 

[121]           Schedule 1, Part 1, entry for Vigabatrin

substitute:

Vigabatrin

Oral powder, sachet 500 mg

Oral

 

Sabril

SW

MP NP

C4929 C14903

P4929

60

5

60

 

 

 

 

 

 

 

 

MP NP

C4929 C14903

P14903

120

5

60

 

 

 

Tablet 500 mg

Oral

 

Sabril

SW

MP NP

C4929 C14903

P4929

100

5

100

 

 

 

 

 

 

 

 

MP NP

C4929 C14903

P14903

200

5

100

 

 

[122]           Schedule 1, Part 1, entry for Vildagliptin

substitute:

Vildagliptin

Tablet 50 mg

Oral

 

Galvus

NV

MP NP

C6346 C6363 C6376 C14978 C14999 C15000

P6346 P6363 P6376

60

5

60

 

 

 

 

 

 

 

 

MP NP

C6346 C6363 C6376 C14978 C14999 C15000

P14978 P14999 P15000

120

5

60

 

 

[123]           Schedule 1, Part 1, entry for Vildagliptin with metformin

substitute:

Vildagliptin with metformin

Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride

Oral

 

Galvumet 50/500

NV

MP NP

C6333 C6344 C6357 C6443 C14887 C14888 C14894

P6333 P6344 P6357 P6443

60

5

60

 

 

 

 

 

 

 

 

MP NP

C6333 C6344 C6357 C6443 C14887 C14888 C14894

P14887 P14888 P14894

120

5

60

 

 

 

Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride

Oral

 

Galvumet 50/850

NV

MP NP

C6333 C6344 C6357 C6443 C14887 C14888 C14894

P6333 P6344 P6357 P6443

60

5

60

 

 

 

 

 

 

 

 

MP NP

C6333 C6344 C6357 C6443 C14887 C14888 C14894

P14887 P14888 P14894

120

5

60

 

 

 

Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride

Oral

 

Galvumet 50/1000

NV

MP NP

C6333 C6344 C6357 C6443 C14887 C14888 C14894

P6333 P6344 P6357 P6443

60

5

60

 

 

 

 

 

 

 

 

MP NP

C6333 C6344 C6357 C6443 C14887 C14888 C14894

P14887 P14888 P14894

120

5

60

 

 

[124]           Schedule 1, Part 1, entry for Zonisamide

substitute:

Zonisamide

Capsule 25 mg

Oral

 

Zonegran

GH

MP NP

C4928 C14883

P4928

56

5

56

 

 

 

 

 

 

 

 

MP NP

C4928 C14883

P14883

112

5

56

 

 

 

Capsule 50 mg

Oral

 

Zonegran

GH

MP NP

C4928 C14883

P4928

56

5

56

 

 

 

 

 

 

 

 

MP NP

C4928 C14883

P14883

112

5

56

 

 

 

Capsule 100 mg

Oral

 

Zonegran

GH

MP NP

C4928 C14883

P4928

112

5

56

 

 

 

 

 

 

 

 

MP NP

C4928 C14883

P14883

224

5

56

 

 

[125]           Schedule 4, Part 1, after entry for Acamprosate

insert:

Acarbose

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[126]           Schedule 4, Part 1, entry for Alendronic acid with colecalciferol

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6306”: P6306

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6307”: P6307

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C6315”: P6315

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C6319”: P6319

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C6320”: P6320

(f)             insert in the column headed “Purposes Code” for the Circumstances Code “C6325”: P6325

(g)           insert in numerical order after existing text:

 

C14898

P14898

 

Osteoporosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Patient must be aged 70 years or older.
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 14898

 

C14993

P14993

 

Established osteoporosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

Compliance with Authority Required procedures - Streamlined Authority Code 14993

 

C15011

P15011

 

Osteoporosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Patient must be aged 70 years or older.
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 15011

 

C15024

P15024

 

Corticosteroid-induced osteoporosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 15024

 

C15032

P15032

 

Corticosteroid-induced osteoporosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 15032

 

C15035

P15035

 

Established osteoporosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

Compliance with Authority Required procedures - Streamlined Authority Code 15035

[127]           Schedule 4, Part 1, entry for Alogliptin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C4349”: P4349

(b)           insert in numerical order after existing text:

 

C14862

P14862

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with alogliptin.

Compliance with Authority Required procedures - Streamlined Authority Code 14862

[128]           Schedule 4, Part 1, entry for Alogliptin with metformin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C4423”: P4423

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C4427”: P4427

(c)           insert in numerical order after existing text:

 

C14876

P14876

 

Diabetes mellitus type 2
Continuing
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and alogliptin.

Compliance with Authority Required procedures - Streamlined Authority Code 14876

[129]           Schedule 4, Part 1, entry for Anastrozole

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5464”: P5464

(b)           insert in numerical order after existing text:

 

C14943

P14943

 

Breast cancer
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must be hormone receptor positive.

 

[130]           Schedule 4, Part 1, entry for Bromocriptine

insert in numerical order after existing text:

 

C14914

P14914

 

Acromegaly
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

 

C14981

P14981

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have had surgery for this condition with incomplete resolution.

 

 

C15017

P15017

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have had radiotherapy for this condition with incomplete resolution.

 

 

C15028

P15028

 

Parkinson disease
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

 

C15043

P15043

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be one in whom surgery is not indicated.

 

 

C15044

P15044

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be one in whom radiotherapy is not indicated.

 

[131]           Schedule 4, Part 1, entry for Cabergoline

insert in numerical order after existing text:

 

C14918

P14918

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be one in whom surgery is not indicated.

 

 

C14959

P14959

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be one in whom radiotherapy is not indicated.

 

 

C14983

P14983

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have had radiotherapy for this condition with incomplete resolution.

 

 

C15005

P15005

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have had surgery for this condition with incomplete resolution.

 

[132]           Schedule 4, Part 1, after entry for Captopril

insert:

Carbamazepine

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

Carbimazole

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[133]           Schedule 4, Part 1, entry for Ciclosporin

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[134]           Schedule 4, Part 1, after entry for Corifollitropin alfa

insert:

Cortisone

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[135]           Schedule 4, Part 1, entry for Cyproterone

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

 

 

P14868

CN14868

Moderate to severe androgenisation
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must not be indicated by acne alone, as this is not a sufficient indication of androgenisation.
Patient must be female.
Patient must not be pregnant.

Compliance with Authority Required procedures - Streamlined Authority Code 14868

[136]           Schedule 4, Part 1, entry for Dapagliflozin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C4991”: P4991

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C5629”: P5629

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C7495”: P7495

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C7506”: P7506

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C7528”: P7528

(f)             insert in the column headed “Purposes Code” for the Circumstances Code “C12477”: P12477

(g)           insert in the column headed “Purposes Code” for the Circumstances Code “C13230”: P13230

(h)           insert in numerical order after existing text:

 

C14859

P14859

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14859

 

C14905

P14905

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with a gliptin and an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14905

 

C14949

P14949

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14949

 

C14974

P14974

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 14974

 

C14976

P14976

 

Chronic heart failure
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.

Compliance with Authority Required procedures - Streamlined Authority Code 14976

[137]           Schedule 4, Part 1, entry for Dapagliflozin with metformin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5631”: P5631

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C5657”: P5657

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C5739”: P5739

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C5798”: P5798

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C7492”: P7492

(f)             insert in the column headed “Purposes Code” for the Circumstances Code “C7498”: P7498

(g)           insert in numerical order after existing text:

 

C14878

P14878

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 14878

 

C14881

P14881

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 14881

 

C14924

P14924

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14924

 

C14987

P14987

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and dapagliflozin.

Compliance with Authority Required procedures - Streamlined Authority Code 14987

[138]           Schedule 4, Part 1, entry for Desmopressin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5226”: P5226

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C5412”: P5412

(c)           insert in numerical order after existing text:

 

C14842

P14842

 

Primary nocturnal enuresis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Patient must be 6 years of age or older.
Patient must be one in whom an enuresis alarm is contraindicated.
The reason that an enuresis alarm is contraindicated must be documented in the patient's medical records when treatment is initiated
No more than twice the maximum quantity will be authorised.

Compliance with Authority Required procedures - Streamlined Authority Code 14842

 

C14945

P14945

 

Primary nocturnal enuresis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Patient must be 6 years of age or older.
Patient must be refractory to an enuresis alarm.
No increase in the maximum quantity or number of units may be authorised.

Compliance with Authority Required procedures - Streamlined Authority Code 14945

 

C14972

P14972

 

Primary nocturnal enuresis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Patient must be 6 years of age or older.
Patient must be refractory to an enuresis alarm.
No more than twice the maximum quantity will be authorised.

Compliance with Authority Required procedures - Streamlined Authority Code 14972

 

C15012

P15012

 

Cranial diabetes insipidus
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures - Streamlined Authority Code 15012

 

C15025

P15025

 

Primary nocturnal enuresis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Patient must be 6 years of age or older.
Patient must be one in whom an enuresis alarm is contraindicated.
The reason that an enuresis alarm is contraindicated must be documented in the patient's medical records when treatment is initiated
No increase in the maximum quantity or number of units may be authorised.

Compliance with Authority Required procedures - Streamlined Authority Code 15025

[139]           Schedule 4, Part 1, entry for Dexamethasone

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[140]           Schedule 4, Part 1, entry for Dutasteride

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6202”: P6202

(b)           insert in numerical order after existing text:

 

C15018

P15018

 

Benign prostatic hyperplasia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have lower urinary tract symptoms; AND
Patient must have moderate to severe benign prostatic hyperplasia; AND
The treatment must be in combination with an alpha-antagonist.

Compliance with Authority Required procedures - Streamlined Authority Code 15018

[141]           Schedule 4, Part 1, entry for Dutasteride with tamsulosin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6189”: P6189

(b)           insert in numerical order after existing text:

 

C15004

P15004

 

Benign prostatic hyperplasia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have lower urinary tract symptoms; AND
Patient must have moderate to severe benign prostatic hyperplasia.

Compliance with Authority Required procedures - Streamlined Authority Code 15004

[142]           Schedule 4, Part 1, entry for Empagliflozin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C4991”: P4991

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C5629”: P5629

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C7495”: P7495

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C7506”: P7506

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C7528”: P7528

(f)             insert in the column headed “Purposes Code” for the Circumstances Code “C12477”: P12477

(g)           insert in the column headed “Purposes Code” for the Circumstances Code “C14471”: P14471

(h)           insert in numerical order after existing text:

 

C14859

P14859

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14859

 

C14905

P14905

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with a gliptin and an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14905

 

C14949

P14949

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14949

 

C14974

P14974

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 14974

 

C14976

P14976

 

Chronic heart failure
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.

Compliance with Authority Required procedures - Streamlined Authority Code 14976

[143]           Schedule 4, Part 1, entry for Empagliflozin with linagliptin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C7524”: P7524

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C7556”: P7556

(c)           insert in numerical order after existing text:

 

C14885

P14885

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14885

[144]           Schedule 4, Part 1, entry for Empagliflozin with metformin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5657”: P5657

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C5798”: P5798

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C5953”: P5953

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C5966”: P5966

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C7492”: P7492

(f)             insert in the column headed “Purposes Code” for the Circumstances Code “C7498”: P7498

(g)           insert in numerical order after existing text:

 

C14878

P14878

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 14878

 

C14881

P14881

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 14881

 

C14924

P14924

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14924

 

C14925

P14925

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and empagliflozin.

Compliance with Authority Required procedures - Streamlined Authority Code 14925

[145]           Schedule 4, Part 1, entry for Eprosartan

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

 

 

P14841

CN14841

Drug interactions expected to occur with all of the base-priced drugs
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures

 

 

P14969

CN14969

Adverse effects occurring with all of the base-priced drugs
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures

 

 

P14970

CN14970

Drug interactions occurring with all of the base-priced drugs
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures

 

 

P15009

CN15009

Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures

[146]           Schedule 4, Part 1, after entry for Essential amino acids formula with vitamins and minerals

insert:

Estradiol

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

Estradiol and estradiol with dydrogesterone

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

Estradiol and estradiol with norethisterone

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

Estradiol with norethisterone

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

Estriol

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[147]           Schedule 4, Part 1, after entry for Etanercept

insert:

Ethosuximide

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[148]           Schedule 4, Part 1, entry for Everolimus

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[149]           Schedule 4, Part 1, entry for Exemestane

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C4796”: P4796

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C5522”: P5522

(c)           insert in numerical order after existing text:

 

C14992

P14992

 

Breast cancer
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must be hormone receptor positive.

 

 

C15031

P15031

 

Metastatic (Stage IV) breast cancer
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
Patient must be receiving PBS-subsidised everolimus concomitantly for this condition.
Patient must not be pre-menopausal.

 

[150]           Schedule 4, Part 1, after entry for Glecaprevir with pibrentasvir

insert:

Glibenclamide

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

Gliclazide

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

Glimepiride

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

Glipizide

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[151]           Schedule 4, Part 1, entry for Hydrocortisone

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[152]           Schedule 4, Part 1, after entry for Ketoprofen

insert:


Labetalol

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[153]           Schedule 4, Part 1, entry for Lacosamide

insert in numerical order after existing text:

 

C14853

P14853

 

Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Must be treated by a neurologist; OR
Must be treated by a paediatrician; AND
Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.
The condition must have failed to be controlled satisfactorily by at least two anti-epileptic drugs prior to when the drug is/was first commenced; AND
The treatment must have been in combination with at least one PBS-subsidised anti-epileptic drug at the time the drug was first commenced.

Compliance with Authority Required procedures - Streamlined Authority Code 14853

 

C14857

P14857

 

Intractable partial epileptic seizures
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14857

[154]           Schedule 4, Part 1, entry for Lamotrigine

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C11081”: P11081

(b)           insert in numerical order after existing text:

 

C14855

P14855

 

Epileptic seizures
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; OR
Patient must be a woman of childbearing potential.

Compliance with Authority Required procedures - Streamlined Authority Code 14855

[155]           Schedule 4, Part 1, entry for Lanthanum

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5491”: P5491

(b)           insert in numerical order after existing text:

 

C14872

P14872

 

Hyperphosphataemia
Maintenance following initiation and stabilisation
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 14872

[156]           Schedule 4, Part 1, entry for Leflunomide

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C13753”: P13753

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C13771”: P13771

(c)           insert in numerical order after existing text:

 

C14941

P14941

 

Severe active psoriatic arthritis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; OR
Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND
The treatment must be initiated by a physician.

 

 

C14942

P14942

 

Severe active rheumatoid arthritis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; OR
Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND
The treatment must be initiated by a physician.

 

[157]           Schedule 4, Part 1, entry for Letrozole

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5464”: P5464

(b)           insert in numerical order after existing text:

 

C14943

P14943

 

Breast cancer
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must be hormone receptor positive.

 

[158]           Schedule 4, Part 1, entry for Levetiracetam

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C11077”: P11077

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C11116”: P11116

(c)           insert in numerical order after existing text:

 

C14964

P14964

 

Partial epileptic seizures
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; OR
Patient must be a woman of childbearing potential; AND
The treatment must not be given concomitantly with brivaracetam, except for cross titration.

Compliance with Authority Required procedures - Streamlined Authority Code 14964

 

C14988

P14988

 

Partial epileptic seizures
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; OR
Patient must be a woman of childbearing potential; AND
Patient must be unable to take a solid dose form of levetiracetam; AND
The treatment must not be given concomitantly with brivaracetam, except for cross titration.

Compliance with Authority Required procedures - Streamlined Authority Code 14988

[159]           Schedule 4, Part 1, entry for Linagliptin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6346”: P6346

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6363”: P6363

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C6376”: P6376

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C7505”: P7505

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C7541”: P7541

(f)             insert in numerical order after existing text:

 

C14858

P14858

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14858

 

C14911

P14911

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14911

 

C14950

P14950

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 14950

 

C14954

P14954

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14954

[160]           Schedule 4, Part 1, entry for Linagliptin with metformin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6333”: P6333

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6336”: P6336

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C6344”: P6344

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C6443”: P6443

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C7507”: P7507

(f)             insert in the column headed “Purposes Code” for the Circumstances Code “C7530”: P7530

(g)           insert in numerical order after existing text:

 

C14888

P14888

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 14888

 

C14891

P14891

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14891

 

C14894

P14894

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 14894

 

C14935

P14935

 

Diabetes mellitus type 2
Continuing
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and linagliptin.

Compliance with Authority Required procedures - Streamlined Authority Code 14935

[161]           Schedule 4, Part 1, entry for Liothyronine

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6382”: P6382

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6410”: P6410

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C6475”: P6475

(d)           insert in numerical order after existing text:

 

C14843

P14843

 

Thyroid cancer
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures - Streamlined Authority Code 14843

 

C14844

P14844

 

Hypothyroidism
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be for replacement therapy; AND
Patient must have documented intolerance to levothyroxine sodium; OR
Patient must have documented resistance to levothyroxine sodium.

Compliance with Authority Required procedures - Streamlined Authority Code 14844

 

C15038

P15038

 

Hypothyroidism
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must be severe hypothyroidism; AND
The treatment must be for initiation of therapy only.

Compliance with Authority Required procedures - Streamlined Authority Code 15038

[162]           Schedule 4, Part 1, entry for Medroxyprogesterone

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5649”: P5649

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C5731”: P5731

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C5791”: P5791

(d)           insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

 

C14965

P14965

 

Breast cancer
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must be hormone receptor positive.

 

 

C14990

P14990

 

Endometrial cancer
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

 

C15007

P15007

 

Advanced breast cancer
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must be hormone receptor positive.

 

 

 

P15030

 

Endometriosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[163]           Schedule 4, Part 1, after entry for Mesna

insert:

Metformin

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[164]           Schedule 4, Part 1, after entry for Methadone

insert:

Methenamine

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[165]           Schedule 4, Part 1, entry for Methotrexate

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[166]           Schedule 4, Part 1, entry for Minoxidil

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5177”: P5177

(b)           insert in numerical order after existing text:

 

C14994

P14994

 

Severe refractory hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be initiated by a consultant physician.

 

[167]           Schedule 4, Part 1, entry for Mycophenolic acid

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[168]           Schedule 4, Part 1, after entry for Nivolumab with relatlimab

insert:

Norethisterone

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[169]           Schedule 4, Part 1, entry for Olmesartan with amlodipine

insert in numerical order after existing text:

 

C14839

P14839

 

Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti-hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker.

 

[170]           Schedule 4, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide

insert in numerical order after existing text:

 

C14837

P14837

 

Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti-hypertensive therapy; AND
The condition must be inadequately controlled with concomitant treatment with two of the following: an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.

 

[171]           Schedule 4, Part 1, entry for Oxcarbazepine

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5183”: P5183

(b)           insert in numerical order after existing text:

 

C14932

P14932

 

Seizures
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have partial epileptic seizures; OR
Patient must have primary generalised tonic-clonic seizures; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs.

Compliance with Authority Required procedures - Streamlined Authority Code 14932

[172]           Schedule 4, Part 1, entry for Oxybutynin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6241”: P6241

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6243”: P6243

(c)           insert in numerical order after existing text:

 

C14915

P14915

 

Detrusor overactivity
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

 

C15006

P15006

 

Detrusor overactivity
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be unable to tolerate oral oxybutynin; OR
Patient must be unable to swallow oral oxybutynin.

 

[173]           Schedule 4, Part 1, entry for Perampanel

insert in numerical order after existing text:

 

C14847

P14847

 

Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
Patient must be aged 12 years or older.

Compliance with Authority Required procedures - Streamlined Authority Code 14847

 

C14852

P14852

 

Intractable partial epileptic seizures
Continuing
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously been issued with an authority prescription for this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14852

[174]           Schedule 4, Part 1, entry for Phenoxymethylpenicillin

insert in numerical order after existing text:

 

 

P14947

 

Recurrent streptococcal infections (including rheumatic fever)
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be for prophylaxis.

 

[175]           Schedule 4, Part 1, after entry for Phenylalanine with carbohydrate

insert:

Phenytoin

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[176]           Schedule 4, Part 1, entry for Pioglitazone

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C4363”: P4363

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C4364”: P4364

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C4388”: P4388

(d)           insert in numerical order after existing text:

 

C15001

P15001

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 15001

 

C15002

P15002

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 15002

 

C15014

P15014

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 15014

[177]           Schedule 4, Part 1, after entry for Piroxicam

insert:

Pizotifen

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[178]           Schedule 4, Part 1, entry for Prednisolone

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[179]           Schedule 4, Part 1, after entry for Prednisolone with phenylephrine

insert:

Prednisone

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[180]           Schedule 4, Part 1, after entry for Pregabalin

insert:

Probenecid

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[181]           Schedule 4, Part 1, entry for Propantheline

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6241”: P6241

(b)           insert in numerical order after existing text:

 

C14915

P14915

 

Detrusor overactivity
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[182]           Schedule 4, Part 1, after entry for Propranolol

insert:

Propylthiouracil

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[183]           Schedule 4, Part 1, entry for Quinagolide

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5136”: P5136

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C5137”: P5137

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C5357”: P5357

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C5398”: P5398

(e)           insert in numerical order after existing text:

 

C14918

P14918

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be one in whom surgery is not indicated.

 

 

C14959

P14959

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be one in whom radiotherapy is not indicated.

 

 

C14983

P14983

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have had radiotherapy for this condition with incomplete resolution.

 

 

C15005

P15005

 

Pathological hyperprolactinaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have had surgery for this condition with incomplete resolution.

 

[184]           Schedule 4, Part 1, entry for Saxagliptin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6346”: P6346

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6363”: P6363

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C7505”: P7505

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C7541”: P7541

(e)           insert in numerical order after existing text:

 

C14858

P14858

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14858

 

C14911

P14911

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14911

 

C14954

P14954

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14954

[185]           Schedule 4, Part 1, entry for Saxagliptin with dapagliflozin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C7524”: P7524

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C7556”: P7556

(c)           insert in numerical order after existing text:

 

C14885

P14885

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14885

[186]           Schedule 4, Part 1, entry for Saxagliptin with metformin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6333”: P6333

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6335”: P6335

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C6344”: P6344

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C7507”: P7507

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C7530”: P7530

(f)             insert in numerical order after existing text:

 

C14888

P14888

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 14888

 

C14891

P14891

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14891

 

C14937

P14937

 

Diabetes mellitus type 2
Continuing
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and saxagliptin.

Compliance with Authority Required procedures - Streamlined Authority Code 14937

[187]           Schedule 4, Part 1, entry for Sevelamer

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5491”: P5491

(b)           insert in numerical order after existing text:

 

C14984

P14984

 

Hyperphosphataemia
Maintenance following initiation and stabilisation
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 14984

[188]           Schedule 4, Part 1, entry for Sirolimus

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[189]           Schedule 4, Part 1, entry for Sitagliptin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6346”: P6346

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6363”: P6363

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C6376”: P6376

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C7505”: P7505

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C7541”: P7541

(f)             insert in numerical order after existing text:

 

C14858

P14858

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14858

 

C14911

P14911

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14911

 

C14950

P14950

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 14950

 

C14954

P14954

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14954

[190]           Schedule 4, Part 1, entry for Sitagliptin with metformin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6333”: P6333

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6334”: P6334

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C6344”: P6344

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C6443”: P6443

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C7507”: P7507

(f)             insert in the column headed “Purposes Code” for the Circumstances Code “C7530”: P7530

(g)           insert in numerical order after existing text:

 

C14888

P14888

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 14888

 

C14891

P14891

 

Diabetes mellitus type 2
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 14891

 

C14894

P14894

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 14894

 

C14933

P14933

 

Diabetes mellitus type 2
Continuing
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and sitagliptin.

Compliance with Authority Required procedures - Streamlined Authority Code 14933

[191]           Schedule 4, Part 1, entry for Sodium acid phosphate

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5089”: P5089

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C5095”: P5095

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C5114”: P5114

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C5123”: P5123

(e)           insert in numerical order after existing text:

 

C14874

P14874

 

Hypophosphataemic rickets
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures - Streamlined Authority Code 14874

 

C14921

P14921

 

Familial hypophosphataemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures - Streamlined Authority Code 14921

 

C14922

P14922

 

Hypercalcaemia
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures - Streamlined Authority Code 14922

 

C14962

P14962

 

Vitamin D-resistant rickets
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures - Streamlined Authority Code 14962

[192]           Schedule 4, Part 1, after entry for Sodium acid phosphate

insert:

Sodium bicarbonate

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[193]           Schedule 4, Part 1, entry for Sucroferric oxyhydroxide

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5491”: P5491

(b)           insert in numerical order after existing text:

 

C14872

P14872

 

Hyperphosphataemia
Maintenance following initiation and stabilisation
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 14872

[194]           Schedule 4, Part 1, after entry for Sulfasalazine

insert:

Sulthiame

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[195]           Schedule 4, Part 1, entry for Tacrolimus

insert in numerical order after existing text:

 

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[196]           Schedule 4, Part 1, entry for Tamoxifen

insert in numerical order after existing text:

 

C14895

P14895

 

Breast cancer
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must be hormone receptor positive.

 

 

C14989

P14989

 

Reduction of breast cancer risk
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have a moderate or high risk of developing breast cancer; AND
The treatment must not exceed a dose of 20 mg per day; AND
The treatment must not exceed a lifetime maximum of 5 years for this condition.

 

[197]           Schedule 4, Part 1, entry for Teriparatide

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C12270”: P12270

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C12492”: P12492

(c)           insert in numerical order after existing text:

 

C14997

P14997

 

Severe established osteoporosis
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously been issued with an authority prescription for this drug; AND
The treatment must not exceed a lifetime maximum of 18 months therapy.
Must be treated by a specialist; OR
Must be treated by a consultant physician.

Compliance with Authority Required procedures - Streamlined Authority Code 14997

[198]           Schedule 4, Part 1, entry for Testosterone

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6324”: P6324

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6910”: P6910

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C6919”: P6919

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C6933”: P6933

(e)           insert in the column headed “Purposes Code” for the Circumstances Code “C6934”: P6934

(f)             insert in numerical order after existing text:

 

C14912

P14912

 

Androgen deficiency
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must not have an established pituitary or testicular disorder; AND
The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs.
Patient must be aged 40 years or older.
Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
Androgen deficiency is defined as:
(i) testosterone level of less than 6 nmol per litre; OR
(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).
Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.
The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.
The name of the specialist must be included in the authority application.

Compliance with Authority Required procedures

 

C14913

P14913

 

Micropenis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

Compliance with Authority Required procedures

 

C14955

P14955

 

Pubertal induction
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

Compliance with Authority Required procedures

 

C14956

P14956

 

Constitutional delay of growth or puberty
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

Compliance with Authority Required procedures

 

C15015

P15015

 

Androgen deficiency
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have an established pituitary or testicular disorder.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

Compliance with Authority Required procedures

[199]           Schedule 4, Part 1, entry for Tiagabine

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C4928”: P4928

(b)           insert in numerical order after existing text:

 

C14883

P14883

 

Partial epileptic seizures
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs.

Compliance with Authority Required procedures - Streamlined Authority Code 14883

[200]           Schedule 4, Part 1, entry for Tobramycin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5520”: P5520

(b)           insert in numerical order after existing text:

 

C15036

P15036

 

Proven Pseudomonas aeruginosa infection
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have cystic fibrosis; AND
Patient must have previously been issued with an authority prescription for tobramycin inhalation capsules; AND
Patient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient's family (in the case of paediatric patients) and the treating physician(s).
Patient must be 6 years of age or older.

Compliance with Authority Required procedures - Streamlined Authority Code 15036

 

C15040

P15040

 

Proven Pseudomonas aeruginosa infection
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have cystic fibrosis; AND
The treatment must be for management.

Compliance with Authority Required procedures - Streamlined Authority Code 15040

[201]           Schedule 4, Part 1, entry for Topiramate

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C5173”: P5173

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C5325”: P5325

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C5516”: P5516

(d)           insert in numerical order after existing text:

 

C14901

P14901

 

Migraine
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be for prophylaxis; AND
Patient must have experienced an average of 3 or more migraines per month over a period of at least 6 months; AND
Patient must have a contraindication to beta-blockers, as described in the relevant TGA-approved Product Information; OR
Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; AND
Patient must have a contraindication to pizotifen because the weight gain associated with this drug poses an unacceptable risk; OR
Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen.
Details of the contraindication and/or intolerance(s) must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 14901

 

C14931

P14931

 

Seizures
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have partial epileptic seizures; OR
Patient must have primary generalised tonic-clonic seizures; OR
Patient must have seizures of the Lennox-Gastaut syndrome; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; AND
Patient must be unable to take a solid dose form of topiramate.

Compliance with Authority Required procedures - Streamlined Authority Code 14931

 

C14973

P14973

 

Seizures
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have partial epileptic seizures; OR
Patient must have primary generalised tonic-clonic seizures; OR
Patient must have seizures of the Lennox-Gastaut syndrome; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs.

Compliance with Authority Required procedures - Streamlined Authority Code 14973

[202]           Schedule 4, Part 1, after entry for Topiramate

insert:

Toremifene

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[203]           Schedule 4, Part 1, after entry for Valine with carbohydrate

insert:

Valproic acid

 

P14238

 

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

[204]           Schedule 4, Part 1, entry for Vigabatrin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C4929”: P4929

(b)           insert in numerical order after existing text:

 

C14903

P14903

 

Epileptic seizures
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs.

Compliance with Authority Required procedures - Streamlined Authority Code 14903

[205]           Schedule 4, Part 1, entry for Vildagliptin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6346”: P6346

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6363”: P6363

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C6376”: P6376

(d)           insert in numerical order after existing text:

 

C14978

P14978

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14978

 

C14999

P14999

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 14999

 

C15000

P15000

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 15000

[206]           Schedule 4, Part 1, entry for Vildagliptin with metformin

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C6333”: P6333

(b)           insert in the column headed “Purposes Code” for the Circumstances Code “C6344”: P6344

(c)           insert in the column headed “Purposes Code” for the Circumstances Code “C6357”: P6357

(d)           insert in the column headed “Purposes Code” for the Circumstances Code “C6443”: P6443

(e)           insert in numerical order after existing text:

 

C14887

P14887

 

Diabetes mellitus type 2
Continuing
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and vildagliptin.

Compliance with Authority Required procedures - Streamlined Authority Code 14887

 

C14888

P14888

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 14888

 

C14894

P14894

 

Diabetes mellitus type 2
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 14894

[207]           Schedule 4, Part 1, entry for Zonisamide

(a)           insert in the column headed “Purposes Code” for the Circumstances Code “C4928”: P4928

(b)           insert in numerical order after existing text:

 

C14883

P14883

 

Partial epileptic seizures
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs.

Compliance with Authority Required procedures - Streamlined Authority Code 14883