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PB 1 of 2020 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
Administered by: Health
Registered 30 Jan 2020
Tabling HistoryDate
Tabled HR04-Feb-2020
Tabled Senate04-Feb-2020
To be repealed 13 May 2020
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

PB 1 of 2020

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 1)

 

National Health Act 1953

________________________________________________________________________

 

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

 

Dated  29th January 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THEA DANIEL

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

1          Name of Instrument

(1)          This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 1).

(2)          This Instrument may also be cited as PB 1 of 2020.

2          Commencement

This Instrument commences on 1 February 2020.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).


 


Schedule 1           Amendments

[1]             Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

                           omit:

 

 

 

a

APO-Alendronate Plus D3 70 mg/70 mcg

TX

MP NP

C6307 C6315 C6320

 

4

5

4

 

 

[2]             Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

                           omit:

 

 

 

a

APO-Alendronate Plus D3 70 mg/140 mcg

TX

MP NP

C6306 C6319 C6325

 

4

5

4

 

 

[3]             Schedule 1, entry for Allopurinol in the form Tablet 100 mg

                           omit:

 

 

 

a

APO-Allopurinol

TX

MP NP

 

 

200

2

200

 

 

[4]             Schedule 1, entry for Allopurinol in the form Tablet 300 mg

                           omit:

 

 

 

a

APO-Allopurinol

TX

MP NP

 

 

60

2

60

 

 

[5]             Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg

                           omit:

 

 

 

a

GenRx Amiodarone

GX

MP NP

C5665

 

30

5

30

 

 

[6]             Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besilate); and Tablet 10 mg (as besilate)

                   (a)        omit:

 

 

 

a

Chem mart Amlodipine

CH

MP NP

 

 

30

5

30

 

 


 

                   (b)        omit:

 

 

 

a

Terry White Chemists Amlodipine

TW

MP NP

 

 

30

5

30

 

 

[7]             Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate)

                   (a)        omit:

 

 

 

a

Chem mart Azithromycin

CH

MP NP

C5637 C5718 C5772

P5718 P5772

2

0

2

 

 

 

 

 

a

Terry White Chemists Azithromycin

TW

MP NP

C5637 C5718 C5772

P5718 P5772

2

0

2

 

 

                   (b)        omit:

 

 

 

a

Chem mart Azithromycin

CH

MP NP

C5637 C5718 C5772

P5637

2

2

2

 

 

 

 

 

a

Terry White Chemists Azithromycin

TW

MP NP

C5637 C5718 C5772

P5637

2

2

2

 

 

[8]             Schedule 1, entry for Baclofen in each of the forms: Tablet 10 mg; and Tablet 25 mg

                           omit:

 

 

 

a

GenRx Baclofen

GX

MP NP

 

 

100

5

100

 

 

[9]             Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg

                           omit:

 

 

 

a

Chem mart Bisoprolol

CH

MP NP

C5324

 

28

5

28

 

 

 

 

 

a

Terry White Chemists Bisoprolol

TW

MP NP

C5324

 

28

5

28

 

 


 

[10]           Schedule 1, entry for Bosentan in each of the forms: Tablet 62.5 mg (as monohydrate); and Tablet 125 mg (as monohydrate)

                           omit:

 

 

 

a

BOSENTAN-DRLA

RZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

 

D(100)

[11]           Schedule 1, entry for Carmellose with glycerin

                           substitute:

Carmellose with glycerin

Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL

Application to the eye

 

Optive

AG

AO NP

C6097

 

1

3

1

 

 

 

 

 

 

 

 

MP

C6079 C6097

P6097

1

3

1

 

 

 

 

 

 

 

 

MP

C6079 C6097

P6079

1

7

1

 

 

[12]           Schedule 1, entry for Celecoxib in the form Capsule 100 mg

                   (a)        omit:

 

 

 

a

Chem mart Celecoxib

CH

MP NP

C4907 C4962

 

60

3

60

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Celecoxib

TW

MP NP

C4907 C4962

 

60

3

60

 

 

[13]           Schedule 1, entry for Celecoxib in the form Capsule 200 mg

                   (a)        omit:

 

 

 

a

Chem mart Celecoxib

CH

MP NP

C4907 C4962

 

30

3

30

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Celecoxib

TW

MP NP

C4907 C4962

 

30

3

30

 

 


 

[14]           Schedule 1, after entry for Cimetidine in the form Tablet 400 mg

                           insert:

Cinacalcet

Tablet 30 mg (as hydrochloride)

Oral

 

Pharmacor Cinacalcet

CR

MP NP

C10068

 

28

5

28

 

 

 

 

 

 

 

 

MP

C10063 C10067 C10073

 

56

5

28

 

C(100)

 

Tablet 60 mg (as hydrochloride)

Oral

 

Pharmacor Cinacalcet

CR

MP NP

C10068

 

28

5

28

 

 

 

 

 

 

 

 

MP

C10063 C10067 C10073

 

56

5

28

 

C(100)

 

Tablet 90 mg (as hydrochloride)

Oral

 

Pharmacor Cinacalcet

CR

MP NP

C10068

 

28

5

28

 

 

 

 

 

 

 

 

MP

C10063 C10067 C10073

 

56

5

28

 

C(100)

[15]           Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Ciprofloxacin GH

HQ

MP NP

C5614 C5615 C5687 C5688 C5689 C5722 C5780

 

14

0

14

 

 

[16]           Schedule 1, entry for Citalopram in each of the forms: Tablet 20 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

NOUMED CITALOPRAM

VO

MP NP

C4755

 

28

5

28

 

 

[17]           Schedule 1, entry for Clarithromycin in the form Tablet 250 mg

                           omit:

 

 

 

a

APO-Clarithromycin

TX

MP NP

 

 

14

1

14

 

 


 

[18]           Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

                   (a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

 

BTC Clopidogrel

JB

MP NP

C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525

 

28

5

28

 

 

                   (b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

 

Clopidogrel APOTEX

GX

MP NP

C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525

 

28

5

28

 

 

[19]           Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

                   (a)        omit: 

 

 

 

 

Chem mart Clopidogrel

CH

MP NP

C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525

 

28

5

28

 

 

                   (b)        omit:

 

 

 

 

Terry White Chemists Clopidogrel

TW

MP NP

C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525

 

28

5

28

 

 

[20]           Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as hyclate)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

 

Doxsig

RW

MP NP

C4475 C4529 C4539

 

25

5

25

 

 

[21]           Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as monohydrate)

                           omit:

 

 

 

 

GenRx Doxycycline

GX

MP NP

C4475 C4529 C4539

 

25

5

25

 

 


 

[22]           Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate)

                   (a)        omit:

 

 

 

 

GenRx Doxycycline

GX

PDP

 

 

7

0

7

 

 

                   (b)        omit:

 

 

 

 

GenRx Doxycycline

GX

MP NP

 

 

7

1

7

 

 

                   (c)        omit:

 

 

 

 

GenRx Doxycycline

GX

MP NP

 

P4485

21

0

21

 

 

                   (d)        omit:

 

 

 

 

GenRx Doxycycline

GX

MP NP

 

P4514

28

0

7

 

 

                   (e)        omit:

 

 

 

 

GenRx Doxycycline

GX

MP

 

P6200

28

5

7

 

 

[23]           Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)

                   (a)        omit:

 

 

 

a

Chem mart Duloxetine

CH

MP NP

C5650

 

28

0

28

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Duloxetine

TW

MP NP

C5650

 

28

0

28

 

 


 

[24]           Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

                   (a)        omit:

 

 

 

a

Chem mart Duloxetine

CH

MP NP

C5650

 

28

5

28

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Duloxetine

TW

MP NP

C5650

 

28

5

28

 

 

[25]           Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

 

EPOPROSTENOL SUN

RA

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

[26]           Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

 

EPOPROSTENOL SUN

RA

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

[27]           Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

                           omit:

 

 

 

a

Escitalopram-DRLA

RZ

MP NP

C4755

 

28

5

28

 

 

[28]           Schedule 1, entry for Ezetimibe with atorvastatin in the form Tablet 10 mg-10 mg

                   (a)        insert in the column headed “Schedule Equivalent” for the existing brand: a

                   (b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Ezetimibe/Atorvastatin GH 10/10

GQ

MP NP

C7958

 

30

5

30

 

 

[29]           Schedule 1, entry for Ezetimibe with atorvastatin in the form Tablet 10 mg-20 mg

                   (a)        insert in the column headed “Schedule Equivalent” for the existing brand: a


 

                   (b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Ezetimibe/Atorvastatin GH 10/20

GQ

MP NP

C7957

 

30

5

30

 

 

[30]           Schedule 1, entry for Ezetimibe with atorvastatin in the form Tablet 10 mg-40 mg

                   (a)        insert in the column headed “Schedule Equivalent” for the existing brand: a

                   (b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Ezetimibe/Atorvastatin GH 10/40

GQ

MP NP

C7957

 

30

5

30

 

 

[31]           Schedule 1, entry for Ezetimibe with atorvastatin in the form Tablet 10 mg-80 mg

                   (a)        insert in the column headed “Schedule Equivalent” for the existing brand: a

                   (b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Ezetimibe/Atorvastatin GH 10/80

GQ

MP NP

C7957

 

30

5

30

 

 

[32]           Schedule 1, entry for Ezetimibe with simvastatin in each of the forms: Tablet 10 mg-10 mg; and Tablet 10 mg-20 mg

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

EZETORIN

RW

MP NP

C7958

 

30

5

30

 

 

[33]           Schedule 1, entry for Ezetimibe with simvastatin in each of the forms: Tablet 10 mg-40 mg; and Tablet 10 mg-80 mg

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

EZETORIN

RW

MP NP

C7957

 

30

5

30

 

 

[34]           Schedule 1, entry for Famciclovir in the form Tablet 125 mg

                           omit from the column headed “Responsible Person”: HX             substitute: IX

[35]           Schedule 1, entry for Famciclovir in each of the forms: Tablet 250 mg; and Tablet 500 mg

                           omit from the column headed “Responsible Person” (all instances): HX     substitute: IX


 

[36]           Schedule 1, entry for Famotidine in the form Tablet 20 mg

                           omit:

 

 

 

a

Famotidine Sandoz

SZ

MP NP

 

 

60

5

60

 

 

[37]           Schedule 1, entry for Famotidine in the form Tablet 40 mg

                           omit:

 

 

 

a

Famotidine Sandoz

SZ

MP NP

 

 

30

5

30

 

 

[38]           Schedule 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 5]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Fenofibrate Sandoz

SZ

MP NP

 

 

30

5

30

 

 

[39]           Schedule 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 11]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Fenofibrate Sandoz

SZ

MP

 

P7640

30

11

30

 

 

[40]           Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

                   (a)        omit:

 

 

 

a

Chem mart Fluoxetine

CH

MP NP

C4755 C6277

 

28

5

28

 

 

                   (b)        omit:

 

 

 

a

GenRx Fluoxetine

GX

MP NP

C4755 C6277

 

28

5

28

 

 

                   (c)        omit:

 

 

 

a

Terry White Chemists Fluoxetine

TW

MP NP

C4755 C6277

 

28

5

28

 

 


 

[41]           Schedule 1, entry for Furosemide in each of the forms: Tablet 20 mg; and Tablet 40 mg

                   (a)        omit:

 

 

 

a

Chem mart Frusemide

CH

MP NP

 

 

100

1

100

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Frusemide

TW

MP NP

 

 

100

1

100

 

 

[42]           Schedule 1, entry for Gabapentin in each of the forms: Capsule 300 mg; Capsule 400 mg; Tablet 600 mg; and Tablet 800 mg

                           omit:

 

 

 

a

GenRx Gabapentin

GX

MP NP

C4928

 

100

5

100

 

 

[43]           Schedule 1, entry for Gliclazide in the form Tablet 80 mg

                           omit:

 

 

 

a

GenRx Gliclazide

GX

MP NP

 

 

100

5

100

 

 

[44]           Schedule 1, entry for Glyceryl trinitrate

                           omit:

 

Tablets 300 micrograms, 100

Buccal/sublingual

 

Nitrostat

PF

PDP

 

 

1

0

1

 

 

 

 

 

 

 

 

MP NP

 

 

1

5

1

 

 

[45]           Schedule 1, entry for Glyceryl trinitrate in the form Tablets 600 micrograms, 100

                   (a)        omit:

 

 

 

 

Nitrostat

PF

PDP

 

 

1

0

1

 

 

                   (b)        omit:

 

 

 

 

Nitrostat

PF

MP NP

 

 

1

5

1

 

 


 

[46]           Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 2 mg in 1 mL

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

MEDSURGE HYDROMORPHONE 2 mg/1 mL

DZ

MP NP

 

 

5

0

5

 

 

[47]           Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 10 mg in 1 mL

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

MEDSURGE HYDROMORPHONE HP 10 mg/
1 mL

DZ

MP NP

 

 

5

0

5

 

 

[48]           Schedule 1, entry for Irbesartan in each the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg

                   (a)        omit:

 

 

 

a

Chem mart Irbesartan

CH

MP NP

 

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Irbesartan

TW

MP NP

 

 

30

5

30

 

 

[49]           Schedule 1, entry for Irbesartan with hydrochlorothiazide in each of the forms: Tablet 150 mg-12.5 mg; Tablet 300 mg-12.5 mg; and
Tablet 300 mg-25 mg

                   (a)        omit:

 

 

 

a

Chem mart Irbesartan HCTZ

CH

MP NP

C4374

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Irbesartan HCTZ

TW

MP NP

C4374

 

30

5

30

 

 


 

[50]           Schedule 1, entry for Isosorbide mononitrate in the form Tablet 60 mg (sustained release)

                   (a)        omit:

 

 

 

a

Chem mart Isosorbide Mononitrate

CH

MP NP

 

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Isosorbide Mononitrate

TW

MP NP

 

 

30

5

30

 

 

[51]           Schedule 1, entry for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre-filled syringe

                   (a)        omit from the column headed “Circumstances”: C8260 C9161

                   (b)        omit from the column headed “Circumstances”: C9323 

                   (c)        insert in numerical order in the column headed “Circumstances”: C10061 C10075 C10077

[52]           Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg

                           omit:

 

 

 

a

APO-Lercanidipine

TX

MP NP

 

 

28

5

28

 

 

 

 

 

a

Blooms the Chemist Lercanidipine

IB

MP NP

 

 

28

5

28

 

 

[53]           Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

NOUMED LEVETIRACETAM

VO

MP NP

C7603

 

60

5

60

 

 

[54]           Schedule 1, after entry for Levodopa with carbidopa in the form Tablet (modified release) 200 mg-50 mg (as monohydrate)

                           insert:

 

Tablet (prolonged release)
200 mg-50 mg

Oral

 

Sinemet CR Prolonged-Release Tablets

MK

MP NP

C5253

 

100

5

60

 

 

[55]           Schedule 1, entry for Lisdexamfetamine

                           insert as first entry:

 

Capsule containing lisdexamfetamine dimesilate
20 mg

Oral

 

Vyvanse

ZI

MP NP

C5252

 

30

5

30

 

 

[56]           Schedule 1, after entry for Lisdexamfetamine in the form Capsule containing lisdexamfetamine dimesilate 30 mg

                           insert:

 

Capsule containing lisdexamfetamine dimesilate
40 mg

Oral

 

Vyvanse

ZI

MP NP

C5252

 

30

5

30

 

 

[57]           Schedule 1, after entry for Lisdexamfetamine in the form Capsule containing lisdexamfetamine dimesilate 50 mg

                           insert:

 

Capsule containing lisdexamfetamine dimesilate
60 mg

Oral

 

Vyvanse

ZI

MP NP

C5252

 

30

5

30

 

 

[58]           Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30
[Maximum Quantity: See Note 2; Number of Repeats: See Note 2]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

APOHEALTH Macrogol with Electrolytes

GX

MP

See Note 2

See Note 2

See Note 2

See Note 2

1

 

C(100)

[59]           Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Maximum Quantity: 1; Number of Repeats: 5]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

APOHEALTH Macrogol with Electrolytes

GX

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

1

5

1

 

 


 

[60]           Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Maximum Quantity: 2; Number of Repeats: 3]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

APOHEALTH Macrogol with Electrolytes

GX

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

2

3

1

 

 

[61]           Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg

                   (a)        omit:

 

 

 

a

Chem mart Metformin XR 500

CH

MP NP

 

 

120

5

120

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Metformin XR 500

TW

MP NP

 

 

120

5

120

 

 

[62]           Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g

                   (a)        omit:

 

 

 

a

Chem mart Metformin XR 1000

CH

MP NP

 

 

60

5

60

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Metformin XR 1000

TW

MP NP

 

 

60

5

60

 

 

[63]           Schedule 1, entry for Moclobemide in the form Tablet 300 mg

                           omit:

 

 

 

a

GenRx Moclobemide

GX

MP NP

C5650

 

60

5

60

 

 


 

[64]           Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 150;
Number of Repeats: 5]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Mycophenolate GH

GQ

MP

 

 

150

5

50

 

 

[65]           Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 300;
Number of Repeats: 5]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Mycophenolate GH

GQ

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

[66]           Schedule 1, entry for Octreotide in the form Injection (modified release) 30 mg (as acetate), vial and diluent syringe

                           insert in numerical order in the column headed “Circumstances”: C10061 C10075 C10077

[67]           Schedule 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)

                           omit:

 

 

 

 

Olanzapine ODT-DRLA

RZ

MP NP

C5856 C5869

 

28

5

28

 

 

[68]           Schedule 1, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating)

                           omit:

 

 

 

 

Olanzapine ODT-DRLA

RZ

MP NP

C5856 C5869

 

28

5

28

 

 

[69]           Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

                   (a)        omit:

 

 

 

a

APOTEX-Pantoprazole

GX

MP NP

C5444 C5512 C5529

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Pantofast 20

RZ

MP NP

C5444 C5512 C5529

 

30

5

30

 

 

[70]           Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 1]

                           omit:

 

 

 

a

APOTEX-Pantoprazole

GX

MP NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

[71]           Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 5]

                           omit:

 

 

 

a

APOTEX-Pantoprazole

GX

MP NP

C8774 C8775 C8776 C8780 C8866

P8776 P8780 P8866

30

5

30

 

 

[72]           Schedule 1, entry for Paroxetine

                           omit:

 

 

 

a

GenRx Paroxetine

GX

MP NP

C4755 C6277 C6636

 

30

5

30

 

 

[73]           Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium)

                           omit:

 

 

 

 

PEMETREXED-DRLA

RZ

MP

 

 

See Note 3

See Note 3

1

 

D(100)

[74]           Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium)

                           omit:

 

 

 

 

Pemetrexed DRLA

RZ

MP

 

 

See Note 3

See Note 3

1

 

D(100)

[75]           Schedule 1, entry for Piroxicam in the form Capsule 10 mg

                   (a)        omit:

 

 

 

a

GenRx Piroxicam

GX

PDP

C6214

 

50

0

50

 

 


 

                   (b)        omit:

 

 

 

a

GenRx Piroxicam

GX

MP NP

C6214

 

50

3

50

 

 

[76]           Schedule 1, entry for Piroxicam in the form Capsule 20 mg

                   (a)        omit:

 

 

 

a

GenRx Piroxicam

GX

PDP

C6214

 

25

0

25

 

 

                   (b)        omit:

 

 

 

a

GenRx Piroxicam

GX

MP NP

C6214

 

25

3

25

 

 

[77]           Schedule 1, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 75 mg; Capsule 150 mg; and Capsule 300 mg

                           omit:

 

 

 

a

APO-Pregabalin

TX

MP NP

C4172

 

56

5

56

 

 

 

 

 

a

Blooms The Chemist Pregabalin

IB

MP NP

C4172

 

56

5

56

 

 

[78]           Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)

                           omit:

 

 

 

a

Rabeprazole-DRLA

RZ

MP NP

C5444 C5512

 

28

5

28

 

 

[79]           Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30;
Number of Repeats: 1]

                   (a)        omit:

 

 

 

a

Chem mart Rabeprazole

CH

MP NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

                   (b)        omit:

 

 

 

a

Rabeprazole-DRLA

RZ

MP NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

 

 

 

a

Terry White Chemists Rabeprazole

TW

MP NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

[80]           Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30;
Number of Repeats: 5]

                   (a)        omit:

 

 

 

a

Chem mart Rabeprazole

CH

MP NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Rabeprazole-DRLA

RZ

MP NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

 

 

 

a

Terry White Chemists Rabeprazole

TW

MP NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

[81]           Schedule 1, entry for Ranitidine

                           omit:

 

Tablet, effervescent, 150 mg (as hydrochloride)

Oral

 

Zantac

AS

MP NP

 

 

60

5

30

 

 

[82]           Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)

                   (a)        omit:

 

 

 

 

Chem mart Ranitidine

CH

MP NP MW

 

 

60

5

60

 

 

                   (b)        omit:

 

 

 

 

Terry White Chemists Ranitidine

TW

MP NP MW

 

 

60

5

60

 

 

                   (c)        insert in the column headed “Schedule Equivalent” for all remaining brands: a


 

[83]           Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)

                   (a)        omit:

 

 

 

a

Chem mart Ranitidine

CH

MP NP

 

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Ranitidine

TW

MP NP

 

 

30

5

30

 

 

[84]           Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 100 mg in 10 mL [Circumstances: See Note 3; Purposes: See Note 3]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Truxima

EW

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

PB(100)

[85]           Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL [Circumstances: See Note 3; Purposes: See Note 3]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Truxima

EW

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

PB(100)

[86]           Schedule 1, entry for Rosuvastatin in each of the forms: Tablet 5 mg (as calcium); Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); and Tablet 40 mg (as calcium)

                   (a)        omit:

 

 

 

a

Rosuvastatin-DRLA

RI

MP NP

 

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Rosuvastatin-DRLA

RI

MP

 

P7598

30

11

30

 

 


 

[87]           Schedule 1, entry for Sapropterin

                           substitute:

Sapropterin

Tablet (soluble) containing sapropterin dihydrochloride
100 mg

Oral

 

Kuvan

IO

MP

C8897 C8898 C8926 C8988 C10076 C10081

P8898

90

0

30

 

 

 

 

 

 

 

 

MP

C8897 C8898 C8926 C8988 C10076 C10081

P8988 P10076

180

0

30

 

 

 

 

 

 

 

 

NP

C8897 C8926 C8988 C10081

P8988

180

0

30

 

 

 

 

 

 

 

 

MP

C8897 C8898 C8926 C8988 C10076 C10081

P8897 P8926 P10081

180

5

30

 

 

 

 

 

 

 

 

NP

C8897 C8926 C8988 C10081

P8897 P8926 P10081

180

5

30

 

 

[88]           Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)

                   (a)        omit:

 

 

 

a

Chem mart Sertraline

CH

MP NP

C4755

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Sertraline

TW

MP NP

C4755

 

30

5

30

 

 

[89]           Schedule 1, entry for Sildenafil

                   (a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

SILDATIO PHT

RW

MP

See Note 3

See Note 3

See Note 3

See Note 3

90

 

D(100)

                   (b)        omit:

 

 

 

a

SILDENAFIL-DRx

RZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

90

 

D(100)

[90]           Schedule 1, entry for Somatropin in the form Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)

                   (a)        omit from the column headed “Circumstances”: C10012

                   (b)        insert in numerical order in the column headed “Circumstances”: C10074

[91]           Schedule 1, entry for Somatropin in the form Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)

                   (a)        omit from the column headed “Circumstances”: C10012

                   (b)        insert in numerical order in the column headed “Circumstances”: C10074

[92]           Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

                           insert in numerical order in the column headed “Circumstances”: C10011 C10027 C10042 C10074

[93]           Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

                   (a)        omit from the column headed “Circumstances”: C10012

                   (b)        insert in numerical order in the column headed “Circumstances”:C10074

[94]           Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)

                   (a)        omit:

 

 

 

a

GenRx Terbinafine

GX

MP NP

C6395 C6404 C6453

P6404 P6453

42

0

42

 

 

                   (b)        omit:

 

 

 

a

GenRx Terbinafine

GX

MP NP

C6395 C6404 C6453

P6395

42

1

42

 

 

[95]           Schedule 1, entry for Tiotropium

                           insert as first entry:

 

Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)

Inhalation by mouth

 

Braltus

TB

MP NP

C6352

 

30

5

30

 

 

[96]           Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release)
150 mg (as hydrochloride)

                   (a)        omit:

 

 

 

a

Chem mart Venlafaxine XR

CH

MP NP

C5650

 

28

5

28

 

 

                   (b)        omit:

 

 

 

a

Terry White Chemists Venlafaxine XR

TW

MP NP

C5650

 

28

5

28

 

 

[97]           Schedule 4, Part 1, entry for Carmellose with glycerin

                   (a)        omit:

 

C6072

P6072

 

Severe dry eye syndrome, including Sjogren's syndrome

 

                   (b)        insert in the column headed “Purposes Code” for the circumstance code “C6097”: P6097

[98]           Schedule 4, Part 1, after entry for Ciclosporin

                           insert:

Cinacalcet

C10063

 

 

Secondary hyperparathyroidism
Continuing treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures - Streamlined Authority Code 10063

 

C10067

 

 

Secondary hyperparathyroidism
Continuing treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures - Streamlined Authority Code 10067

 

C10068

 

 

Secondary hyperparathyroidism
Continuing treatment
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have achieved a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment; OR
Patient must have an intact parathyroid (iPTH) concentration greater than 15 pmol/L and an (adjusted) serum calcium concentration of less than 2.6 mmol/L after 6 months.
During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures - Streamlined Authority Code 10068

 

C10073

 

 

Secondary hyperparathyroidism
Initial treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have failed to respond to conventional therapy; AND
Patient must have sustained hyperparathyroidism with iPTH of at least 50 pmol per L; OR
Patient must have sustained hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L.
During the titration phase, intact PTH (iPTH) should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.
During the titration phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures

[99]           Schedule 4, Part 1, entry for Lanreotide

                   (a)        omit:

 

C8260

 

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
Lanreotide is not PBS-subsidised for use in combination with everolimus or sunitinib for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 8260

 

C9161

 

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
Lanreotide is not PBS-subsidised for use in combination with everolimus or sunitinib for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9161

                   (b)        omit:

 

C9323

 

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
Lanreotide is not PBS-subsidised for use in combination with everolimus or sunitinib for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9323

                   (c)        insert in numerical order after existing text:

 

C10061

 

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10061

 

C10075

 

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10075

 

C10077

 

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10077

[100]        Schedule 4, Part 1, entry for Octreotide

                           insert in numerical order after existing text:

 

C10061

 

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10061

 

C10075

 

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10075

 

C10077

 

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10077

[101]        Schedule 4, Part 1, entry for Sapropterin

                   (a)        omit:

 

C4773

P4773

 

Hyperphenylalaninaemia
Continuing
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have previously been issued with an authority prescription for this drug; OR
Patient must have accessed non-PBS-subsidised treatment prior to 1 May 2014.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.
The authority application must be made in writing.

Compliance with Written Authority Required procedures

 

C4921

P4921

 

Hyperphenylalaninaemia
Initial
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.
The authority application must be made in writing.

Compliance with Written Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C10076

P10076

 

Hyperphenylalaninaemia
Initial treatment
Must be treated by a metabolic physician.
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.

Compliance with Authority Required procedures

 

C10081

P10081

 

Hyperphenylalaninaemia
Continuing treatment
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have previously been issued with an authority prescription for this drug; OR
Patient must have accessed non-PBS-subsidised treatment prior to 1 May 2014.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.

Compliance with Authority Required procedures


 

[102]        Schedule 4, Part 1, entry for Somatropin

                   (a)        omit:

 

C10012

 

 

Severe growth hormone deficiency
Continuing treatment in adults
Must be treated by an endocrinologist or in consultation with an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR
Patient must have adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease; AND
Patient must maintain IGF-1 levels within the normal range for age and sex.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application.

Compliance with Written Authority Required procedures

                    (b)       insert in numerical order after existing text:

 

C10074

 

 

Severe growth hormone deficiency
Continuing treatment in a person with a mature skeleton or aged 18 years or older
Must be treated by an endocrinologist or in consultation with an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton; OR
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient aged 18 years or older; AND
Patient must maintain IGF-1 levels within the normal range for age and sex.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application.

Compliance with Written Authority Required procedures

[103]        Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate) [GRP-15475]

                   (a)        insert in alphabetical order in the column headed “Brand”: BTC Clopidogrel

                   (b)        insert in alphabetical order in the column headed “Brand”: Clopidogrel APOTEX

[104]        Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-15475]

                   (a)        omit from the column headed “Brand”: Chem mart Clopidogrel

                   (b)        omit from the column headed “Brand”: Terry White Chemists Clopidogrel


 

[105]        Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate) [GRP-17110]

                   (a)        insert in alphabetical order in the column headed “Brand”: BTC Clopidogrel

                   (b)        insert in alphabetical order in the column headed “Brand”: Clopidogrel APOTEX

[106]        Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-17110] 

                   (a)        omit from the column headed “Brand”: Chem mart Clopidogrel

                   (b)        omit from the column headed “Brand”: Terry White Chemists Clopidogrel

[107]        Schedule 5, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [GRP-14639]

                           omit from the column headed “Brand”: GenRx Doxycycline

[108]        Schedule 5, entry for Doxycycline in the form Tablet 50 mg (as hyclate) [GRP-15635]

                           insert in alphabetical order in the column headed “Brand”: Doxsig

[109]        Schedule 5, entry for Doxycycline in the form Tablet 50 mg (as monohydrate) [GRP-15635] 

                           omit from the column headed “Brand”: GenRx Doxycycline

[110]        Schedule 5, after entry for Doxycycline

                           insert:

Epoprostenol

GRP-16914

Powder for I.V. infusion 500 micrograms (as sodium)

Injection

EPOPROSTENOL SUN
Veletri

 

 

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

 

GRP-16976

Powder for I.V. infusion 1.5 mg (as sodium)

Injection

EPOPROSTENOL SUN
Veletri

 

 

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

[111]        Schedule 5, after entry for Levodopa with carbidopa in the form Tablet (modified release) 200 mg-50 mg (as monohydrate) [GRP-22957]

                           insert:

 

 

Tablet (prolonged release) 200 mg-50 mg

Oral

Sinemet CR Prolonged-Release Tablets

[112]        Schedule 5, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating) [GRP-15723]

                           omit from the column headed “Brand”: Olanzapine ODT-DRLA

[113]        Schedule 5, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating) [GRP-15797]

                           omit from the column headed “Brand”: Olanzapine ODT-DRLA

[114]        Schedule 5, omit entry for Ranitidine

[115]        Schedule 5, after entry for Tenofovir with emtricitabine and efavirenz

                           insert:

Tiotropium

GRP-23704

Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)

Inhalation by mouth

Braltus

 

 

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)

Inhalation by mouth

Spiriva