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PB 27 of 2012 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to provide for additions, deletions and changes to drugs, forms, brands, responsible person codes, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 26 Apr 2012
Tabling HistoryDate
Tabled HR08-May-2012
Tabled Senate10-May-2012
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

PB 27 of 2012

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No.3)
1

National Health Act 1953

I, KIM BESSELL, First Assistant Secretary (Acting), Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 18 April 2012

 

 

 

 

 

 

 

 

 

 

 

KIM BESSELL

First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health and Ageing


 


1          Name of Instrument

            (1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 3).

            (2)        This Instrument may also be cited as PB 27 of 2012.

2          Commencement

            This Instrument commences on 1 May 2012.

3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)

            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).



Schedule 1     Amendments

 

[1]           Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)

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

 

 

 

Densate 70

DO

MP NP

C2646 C3070 C3933

 

4

5

 

[2]           Schedule 1, entry for Anastrozole

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

 

 

 

Anastrozole Synthon

ZT

MP NP

C2213

 

30

5

 

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

 

 

 

Arianna

AF

MP NP

C2213

 

30

5

 

[3]           Schedule 1, entry for Bicalutamide

omit from the column headed “Responsible Person” for the brand “Cosudex”:                  AP          substitute:             SZ

[4]           Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 2.5 mg

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

 

 

 

Beprol 2.5

DO

MP NP

C3234

 

28

5

 

[5]           Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 5 mg

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

 

 

 

Beprol 5

DO

MP NP

C3234

 

28

5

 

[6]           Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 10 mg

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

 

 

 

Beprol 10

DO

MP NP

C3234

 

28

5

 

[7]           Schedule 1, entry for Bivalirudin

omit from the column headed “Responsible Person”:                 CS          substitute:             XM

[8]           Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 50 mg in 5 mL

omit:

 

 

 

Pfizer Australia Pty Ltd

PF

MP

 

 

See Note 3

See Note 3

D

[9]           Schedule 1, entry for Carvedilol in the form Tablet 3.125 mg

omit:

 

 

 

Kredex

MD

MP NP

C1735 C3234

 

30

0

 

[10]         Schedule 1, entry for Cisplatin

omit:

 

I.V. injection 10 mg in 10 mL

Injection

Pfizer Australia Pty Ltd

PF

MP

 

 

See Note 3

See Note 3

D

[11]         Schedule 1, entry for Darunavir

omit:

 

Tablet 300 mg (as ethanolate)

Oral

Prezista

JC

MP
See Note 1

C3594 C3595

 

240

5

D

[12]         Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial

omit:

 

 

 

Adriamycin Solution

PF

MP

 

 

See Note 3

See Note 3

D

[13]         Schedule 1, entry for Doxorubicin

omit:

 

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 20 mg in 10 mL single dose vial

Injection/ intravesical

Adriamycin Solution

PF

MP

 

 

See Note 3

See Note 3

D


[14]         Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL

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

 

 

 

Lipodox

ZF

MP

C1568 C1795 C1796 C3905 C3910 C3911

 

See Note 3

See Note 3

D

 

 

 

 

 

MP
See Note 1

C1828 C1829 C3348 C3349

 

4

5

D

[15]         Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL

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

 

 

 

Lipodox 50

ZF

MP

C1568 C1795 C1796 C3905 C3910 C3911

 

See Note 3

See Note 3

D

[16]         Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; and Tablet containing enalapril maleate 10 mg

omit:

 

 

 

Enalapril Winthrop

WA

MP NP

 

 

30

5

 

[17]         Schedule 1, entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL; and Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL

omit:

 

 

 

Pharmorubicin Solution

PF

MP

 

 

See Note 3

See Note 3

D

[18]         Schedule 1, entry for Etravirine

omit:

 

Tablet 100 mg

Oral

Intelence

JC

MP
See Note 1

C3596 C3597

 

240

5

D

[19]         Schedule 1, entry for Glucose Indicator—Blood

omit:

 

Test strips, 50 (Advantage II)

For external use

Advantage II

RD

MP NP

 

 

2

5

 

 

 

 

 

 

MP

 

P3035

2

11

 

[20]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

omit:

 

 

 

Camptosar

PF

MP

C3184

 

See Note 3

See Note 3

D

[21]         Schedule 1, entry for Letrozole in the form Tablet 2.5 mg

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

 

 

 

Letrozole-Synthon

ZT

MP NP

C1608 C2691 C2692

 

30

5

 

[22]         Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg

omit:

 

 

 

Lisinopril Winthrop

WA

MP NP

 

 

30

5

 

[23]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

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

 

 

 

Glucobete 500

DO

MP NP

 

 

100

5

 

[24]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

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

 

 

 

Glucobete 850

DO

MP NP

 

 

60

5

 


[25]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

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

 

 

 

Glucobete 1000

DO

MP NP

 

 

90

5

 

[26]         Schedule 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)

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

 

 

 

Milivin OD 15

DO

MP NP

C1211

 

30

5

 

[27]         Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

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

 

 

 

Aurozapine 30

DO

MP NP

C1211

 

30

5

 

[28]         Schedule 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)

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

 

 

 

Milivin OD 30

DO

MP NP

C1211

 

30

5

 

[29]         Schedule 1, entry for Mirtazapine in the form Tablet 45 mg

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

 

 

 

Aurozapine 45

DO

MP NP

C1211

 

30

5

 

[30]         Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)

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

 

 

 

Milivin OD 45

DO

MP NP

C1211

 

30

5

 


[31]         Schedule 1, entry for Mitozantrone

omit:

 

Injection 10 mg (as hydrochloride) in 5 mL

Injection

Pfizer Australia Pty Ltd

PF

MP

 

 

See Note 3

See Note 3

D

[32]         Schedule 1, entry for Mitozantrone in the form Injection 25 mg (as hydrochloride) in 12.5 mL

omit:

 

 

 

Pfizer Australia Pty Ltd

PF

MP

 

 

See Note 3

See Note 3

D

[33]         Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg [Max Quantity 150; Number of Repeats 3]

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

 

 

 

Pharmacor Mycophenolate 500

CR

MP

C1765 C1766

 

150

3

 

[34]         Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg [Max Quantity 300; Number of Repeats 5]

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

 

 

 

Pharmacor Mycophenolate 500

CR

MP
See Note 1

C1650 C1651 C3355 C3356

 

300

5

C

[35]         Schedule 1, entry for Naproxen

omit:

 

Oral suspension 125 mg per 5 mL, 474 mL

Oral

Naprosyn

RO

MP NP

C2270 C2271 C3647 C3648

P3648

1

0

 

 

 

 

 

 

MP NP

C2270 C2271 C3647 C3648

P2270 P2271 P3647

1

3

 

[36]         Schedule 1, entry for Natalizumab 

substitute:

Natalizumab

Solution concentrate for I.V. infusion 300 mg in 15 mL

Injection

Tysabri

BD

MP
See Note 1

C3423 C3424 C3425

 

1

5

D

[37]         Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg (as benzoate); Tablet 5 mg (as benzoate); Tablet 7.5 mg (as benzoate); and Tablet 10 mg (as benzoate)

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

 

 

 

Olanzapine-Synthon

ZT

MP NP

C1589 C2044

 

28

5

 

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

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

 

 

 

Olanzapine ODT generichealth 5

GQ

MP NP

C1589 C2044

 

28

5

 

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

 

 

 

Olanzapine Sandoz ODT 5

SZ

MP NP

C1589 C2044

 

28

5

 

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

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

 

 

 

Olanzapine ODT generichealth 10

GQ

MP NP

C1589 C2044

 

28

5

 

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

 

 

 

Olanzapine Sandoz ODT 10

SZ

MP NP

C1589 C2044

 

28

5

 

[40]         Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

(a)        omit:

 

 

 

Ondasetron-DRLA

RZ

MP NP

C3050 C3611

P3611

10

1

 

 

 

 

Ondasetron Tabs Pfizer

FZ

MP NP

C3611

P3611

10

1

 

 


substitute:

 

 

 

Ondansetron-DRLA

RZ

MP NP

C3050 C3611

P3611

10

1

 

 

 

 

Ondansetron Tabs Pfizer

FZ

MP NP

C3050 C3611

P3611

10

1

 

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

 

 

 

Zilfojim 4

DO

MP NP

C3050 C3611

P3611

10

1

 

[41]         Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

(a)        omit:

 

 

 

Ondasetron Tabs Pfizer

FZ

MP NP

C3611

P3611

10

1

 

substitute:

 

 

 

Ondansetron Tabs Pfizer

FZ

MP NP

C3050 C3611

P3611

10

1

 

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

 

 

 

Zilfojim 8

DO

MP NP

C3050 C3611

P3611

10

1

 

[42]         Schedule 1, entry for Ondansetron in the form I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL

omit:

 

 

 

Pfizer Australia Pty Ltd

PF

MP NP
See Note 1

C3050 C3611
See Note 2

See Note 2

1
See Note 2

0
See Note 2

 

[43]         Schedule 1, entry for Ondansetron in the form I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

omit:

 

 

 

Pfizer Australia Pty Ltd

PF

MP NP
See Note 1

C3050 C3611
See Note 2

See Note 2

1
See Note 2

0
See Note 2

 


[44]         Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg

omit:

 

 

 

Winthrop Oxaliplatin

WA

MP

C3900 C3901 C3930 C3939

 

See Note 3

See Note 3

D

[45]         Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 2]

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

 

 

 

Torzole 40

TA

MP NP

C1177 C1337 C1476 C1533

P1177

30

2

 

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

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

 

 

 

Torzole 40

TA

MP NP

C1177 C1337 C1476 C1533

P1337 P1476 P1533

30

5

 

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

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

 

 

 

Torzole 20

TA

MP NP

C1337 C1476 C1533

 

30

5

 

[48]         Schedule 1, entry for Pimecrolimus

omit from the column headed “Responsible Person”:                 NV          substitute:             HM

[49]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Pravastatin Actavis 10

TA

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[50]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Pravastatin Actavis 10

TA

MP

C1540 C3047

P3047

30

11

 

[51]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Pravastatin Actavis 20

TA

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[52]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Pravastatin Actavis 20

TA

MP

C1540 C3047

P3047

30

11

 

[53]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Pravastatin Actavis 40

TA

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[54]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Pravastatin Actavis 40

TA

MP

C1540 C3047

P3047

30

11

 


[55]         Schedule 1, entry for Promethazine

omit:

 

Tablet containing promethazine hydrochloride 10 mg

Oral

Phenergan

SW

MP NP

C3640 C3641

P3641

50

0

 

 

 

 

 

 

MP NP

C3640 C3641

P3640

50

3

 

 

Tablet containing promethazine hydrochloride 25 mg

Oral

Phenergan

SW

MP NP

C3640 C3641

P3641

50

0

 

 

 

 

 

 

MP NP

C3640 C3641

P3640

50

3

 

 

Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL

Oral

Phenergan

SW

MP NP

C3640 C3641

P3641

1

0

 

 

 

 

 

 

MP NP

C3640 C3641

P3640

1

3

 

[56]         Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

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

 

 

 

Seronia 25

QA

MP NP

C1589 C2044 C2765

 

60

5

 

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

 

 

 

Syquet

AF

MP NP

C1589 C2044 C2765

 

60

5

 

[57]         Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

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

 

 

 

Seronia 100

QA

MP NP

C1589 C2044 C2765

 

90

5

 

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

 

 

 

Syquet

AF

MP NP

C1589 C2044 C2765

 

90

5

 


[58]         Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

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

 

 

 

Seronia 200

QA

MP NP

C1589 C2044 C2765

 

60

5

 

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

 

 

 

Syquet

AF

MP NP

C1589 C2044 C2765

 

60

5

 

[59]         Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

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

 

 

 

Seronia 300

QA

MP NP

C1589 C2044 C2765

 

60

5

 

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

 

 

 

Syquet

AF

MP NP

C1589 C2044 C2765

 

60

5

 

[60]         Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 20 mg (as hydrochloride)

(a)        omit:

 

 

 

Filpril

FZ

MP NP

 

 

30

5

 

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

 

 

 

Quinapril Pfizer

FZ

MP NP

 

 

30

5

 

 

 

[61]         Schedule 1, entry for Ramipril in the form Tablet 1.25 mg

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

 

 

 

Ramipril Tabs Pfizer

FZ

MP NP

 

 

30

5

 

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

 

 

 

Vascalace 1.25

DO

MP NP

 

 

30

5

 

[62]         Schedule 1, entry for Ramipril in the form Tablet 2.5 mg

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

 

 

 

Ramipril Tabs Pfizer

FZ

MP NP

 

 

30

5

 

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

 

 

 

Vascalace 2.5

DO

MP NP

 

 

30

5

 

[63]         Schedule 1, entry for Ramipril in the form Tablet 5 mg

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

 

 

 

Ramipril Tabs Pfizer

FZ

MP NP

 

 

30

5

 

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

 

 

 

Vascalace 5

DO

MP NP

 

 

30

5

 

[64]         Schedule 1, entry for Ramipril in the form Tablet 10 mg

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

 

 

 

Ramipril Tabs Pfizer

FZ

MP NP

 

 

30

5

 

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

 

 

 

Vascalace 10

DO

MP NP

 

 

30

5

 

[65]         Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 2]

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

 

 

 

Risperidone Actavis 0.5

TA

MP NP

C1589 C2061 C3083

P2061 P3083

60

2

 

[66]         Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 5]

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

 

 

 

Risperidone Actavis 0.5

TA

MP NP

C1589 C2061 C3083

P1589

60

5

 

[67]         Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 2]

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

 

 

 

Risperidone Actavis 1

TA

MP NP

C1589 C2061 C2272 C3083

P2061 P3083

60

2

 

[68]         Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 5]

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

 

 

 

Risperidone Actavis 1

TA

MP NP

C1589 C2061 C2272 C3083

P1589 P2272

60

5

 

[69]         Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 2]

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

 

 

 

Risperidone Actavis 2

TA

MP NP

C1589 C2272 C3083

P3083

60

2

 


[70]         Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 5]

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

 

 

 

Risperidone Actavis 2

TA

MP NP

C1589 C2272 C3083

P1589 P2272

60

5

 

[71]         Schedule 1, entry for Risperidone in the form Tablet 3 mg

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

 

 

 

Risperidone Actavis 3

TA

MP NP

C1589 C2272

 

60

5

 

[72]         Schedule 1, entry for Risperidone in the form Tablet 4 mg

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

 

 

 

Risperidone Actavis 4

TA

MP NP

C1589 C2272

 

60

5

 

[73]         Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)

omit:

 

 

 

Sertraline Winthrop

WA

MP NP

C1211

 

30

5

 

[74]         Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Synthon Simvastatin

ZT

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[75]         Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Synthon Simvastatin

ZT

MP

C1540 C3047

P3047

30

11

 


[76]         Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Synthon Simvastatin

ZT

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[77]         Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Synthon Simvastatin

ZT

MP

C1540 C3047

P3047

30

11

 

[78]         Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 5]

(a)        omit from the column headed “Responsible Person” for the brand “Simvahexal”:                             SZ          substitute:                HX

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

 

 

 

Simvastatin Sandoz

SZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

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

 

 

 

Synthon Simvastatin

ZT

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[79]         Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]

(a)        omit from the column headed “Responsible Person” for the brand “Simvahexal”:                             SZ          substitute:                HX

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

 

 

 

Simvastatin Sandoz

SZ

MP

C1540 C3047

P3047

30

11

 

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

 

 

 

Synthon Simvastatin

ZT

MP

C1540 C3047

P3047

30

11

 

[80]         Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Synthon Simvastatin

ZT

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[81]         Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Synthon Simvastatin

ZT

MP

C1540 C3047

P3047

30

11

 

[82]         Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg

omit:

 

 

 

Topiramate generichealth

GQ

MP NP

C2797 C2799

 

60

5

 

[83]         Schedule 1, entry for Topiramate in each of the forms: Tablet 100 mg; and Tablet 200 mg

omit:

 

 

 

Topiramate generichealth

GQ

MP NP

C2797

 

60

5

 

[84]         Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Shilova 500

DO

MP NP

C3622 C3623 C3624 C3631 C3632

P3623 P3624

30

5

 

[85]         Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)

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

 

 

 

Altven

FZ

MP NP

C1211

 

28

0

 


[86]         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)

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

 

 

 

Altven

FZ

MP NP

C1211

 

28

5

 

[87]         Schedule 1, entry for Vincristine in the form I.V. injection containing vincristine sulfate 1 mg in 1 mL

omit:

 

 

 

Pfizer Australia Pty Ltd

PF

MP

 

 

See Note 3

See Note 3

D

[88]         Schedule 3, details relevant to Responsible person code GZ

omit:

 

Genzyme Australasia Pty Ltd

 24 083 420 526

substitute:

 

sanofi-aventis Australia Pty Ltd

 31 008 558 807

[89]         Schedule 3, after details relevant to Responsible person code HL

insert:

HM

Meda Pharmaceuticals Pty Ltd

 59 155 308 679

[90]         Schedule 3, after details relevant to Responsible person code XF

insert:

XM

The Medicines Company (Australia) Pty Limited

 74 138 555 021

[91]         Schedule 3, after details relevant to Responsible person code ZP

insert:

ZT

Synthon A.U. Pty Ltd

 58 080 948 698


[92]         Schedule 4, Part 1, entry for Clopidogrel [Circumstances Code C3879]

omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:

Compliance with
Authority Required procedures – Streamlined Authority
Code 3879

[93]         Schedule 4, Part 1, entry for Clopidogrel with aspirin [Circumstances Code C3880]

omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:

Compliance with
Authority Required procedures – Streamlined Authority
Code 3880

[94]         Schedule 4, Part 1, entry for Deferasirox [Circumstances Code C3828]

omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:

Compliance with
Written or Telephone
Authority Required procedures – Streamlined Authority
Code 3828

[95]         Schedule 4, Part 1, entry for Filgrastim [Circumstances Code C3834]

omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:

Compliance with
Written or Telephone
Authority Required procedures – Streamlined Authority
Code 3834


[96]         Schedule 4, Part 1, after entry for Naratriptan

insert:

Natalizumab

C3423

 

Where the patient is receiving treatment at/from a private hospital

Initial treatment, as monotherapy, by a neurologist, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient 18 years of age or older who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain and/or spinal cord and the date of the scan is included in the authority application, unless the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient

Compliance with Written or Telephone Authority Required procedures

 

C3424

 

Where the patient is receiving treatment at/from a private hospital

Continuing treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in a patient previously issued with an authority prescription for this drug who does not show continuing progression of disability while on treatment with this drug, and who has demonstrated compliance with, and an ability to tolerate, this therapy.

Compliance with Written or Telephone Authority Required procedures

 

C3425

 

Where the patient is receiving treatment at/from a public hospital

Treatment, as monotherapy, by a neurologist, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient 18 years of age or older who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years, and where:
the diagnosis is confirmed by magnetic resonance imaging of the brain and/or spinal cord and the date of the scan is included in the patient's medical notes, unless written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient is included in the patient's medical notes;
natalizumab must be ceased if there is continuing progression of disability while on treatment with natalizumab;
for continued treatment the patient must demonstrate compliance with, and an ability to tolerate, natalizumab

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3425



[97]         Schedule 4, Part 1, entry for Pegfilgrastim [Circumstances Code C3834]

omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:

Compliance with
Written or Telephone
Authority Required procedures – Streamlined Authority
Code 3834

[98]         Schedule 4, Part 1, omit entry for Promethazine

[99]         Schedule 4, Part 1, entry for Risperidone [Circumstances Code C3841]

omit from the column headed “Authority Requirements – Part of Circumstances”:       C3841    substitute:             3841

[100]       Schedule 4, Part 1, entry for Tipranavir [Circumstances Codes C3601; C3602; and C3603]

omit from the column headed “Authority Requirements – Part of Circumstances”:       Authority Authority         substitute:           Authority

 

 

 

 

 

 

 

1Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 

See http://www.frli.gov.au.