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PB 31 of 2011 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010) and provides for additions, deletions and changes to forms, brands, responsible persons, circumstances for prescribing, and to the maximum quantities and number of repeats that may be prescribed.
Administered by: Health
Registered 13 Apr 2011
Tabling HistoryDate
Tabled HR10-May-2011
Tabled Senate10-May-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

PB 31 of 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No. 5)1

National Health Act 1953

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

Dated 11 April 2011

 

 

 

 

 

 

 

 

 

 

 

FELICITY McNEILL

Acting First Assistant Secretary

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 2011 (No. 5).

            (2)        This Instrument may also be cited as PB 31 of 2011.

2          Commencement

            This Instrument commences on 1 May 2011.

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 Alprazolam in each of the forms: Tablet 1 mg; and Tablet 2 mg

omit:

 

 

 

Alprazolam-GA

GN

MP NP

C1975

 

50

2

 

[2] Schedule 1, entry for Aspirin in the form Tablet 100 mg

omit:

 

 

 

DBL Aspirin 100 mg

GY

MP NP

 

 

112

1

 

[3] Schedule 1, entry for Atropine

substitute:

Atropine

Injection containing atropine sulfate 600 micrograms in 1 mL

Injection

Pfizer Australia Pty Ltd

PF

PDP

 

 

10

0

 

 

 

 

 

 

MP NP

 

 

10

1

 

 

Eye drops containing atropine sulfate 10 mg per mL, 15 mL

Application to the eye

Atropt

SI

MP NP

 

 

1

2

 

[4] Schedule 1, omit entry for Copper Sulfate

[5] Schedule 1, entry for Diazepam in the form Tablet 2 mg

(a)           insert in the columns in the order indicated after the first instance of the brand “Antenex 2”:

 

 

 

APO-Diazepam

TX

MP NP PDP

 

 

50

0

 

 

 

 

 

 

MP NP

 

P3656

50

0

 

(b)           insert in the columns in the order indicated after the second instance of the brand “Antenex 2”:

 

 

 

APO-Diazepam

TX

MP NP

 

P3655

50

3

 

[6] Schedule 1, entry for Diazepam in the form Tablet 5 mg     

(a)           insert in the columns in the order indicated after the first instance of the brand “Antenex 5”:

 

 

 

APO-Diazepam

TX

MP NP PDP

 

 

50

0

 

 

 

 

 

 

MP NP

 

P3656

50

0

 

(b)           insert in the columns in the order indicated after the second instance of the brand “Antenex 5”:

 

 

 

APO-Diazepam

TX

MP NP

 

P3655

50

3

 

[7] Schedule 1, after entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL

insert in the columns in the order indicated:

 

Solution concentrate for I.V. infusion 160 mg in 16 mL

Injection

DBL Docetaxel Concentrated Injection

HH

MP

See Note 1

C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428

 

1

0

 

[8] Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

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

 

 

 

Escicor 10

MI

MP NP

C1211

 

28

5

 

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

 

 

 

Pharmacor Escitalopram 10

CR

MP NP

C1211

 

28

5

 

[9] Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

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

 

 

 

Escicor 20

MI

MP NP

C1211

 

28

5

 

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

 

 

 

Pharmacor Escitalopram 20

CR

MP NP

C1211

 

28

5

 

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

(a)           omit:

 

 

 

Fluoxebell

BF

MP NP

C1211 C1241

 

28

5

 

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

 

 

 

Fluoxetine RBX

RA

MP NP

C1211 C1241

 

28

5

 

[11]         Schedule 1, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL

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

 

 

 

Calcium Folinate Ebewe

IT

MP NP

See Note 1

 

 

4

1

 

[12]         Schedule 1, after entry for Interferon Beta-1a in the form Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre-filled syringe

insert in the columns in the order indicated:

 

Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose autoinjector

Injection

Rebif 44

SG

MP

C1175 C1751

 

12

5

 

[13]         Schedule 1, after entry for Levodopa with Carbidopa in the form Tablet 250 mg-25 mg (anhydrous)

insert in the columns in the order indicated:

 

Intestinal gel 20 mg-5 mg per mL, 100 mL

Intra-intestinal

Duodopa

AB

MP NP

C3703

 

56

5

 

 

 

 

 

 

MP
See Note 1

C3704 C3705

 

56

5

C

[14]         Schedule 1, entry for Lisinopril in the form Tablet 10 mg

omit:

 

 

 

Lisinopril Hexal

HX

MP NP

 

 

30

5

 

[15]         Schedule 1, entry for Mefenamic Acid

omit from the column headed “Responsible Person”: PD and substitute: PF

[16]         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”:

 

 

 

APO-Metformin 500

TX

MP NP

 

 

100

5

 

[17]         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”:

 

 

 

APO-Metformin 850

TX

MP NP

 

 

60

5

 

[18]         Schedule 1, entry for Morphine

substitute:

Morphine

Tablet containing morphine sulfate 10 mg

Oral

Sevredol

MF

MP NP

C1789 C3661 C3662

P1789 P3662

20

0

 

 

 

 

 

 

MP NP

C1789 C3661 C3662

P3661

20

2

 

 

Tablet containing morphine sulfate 20 mg

Oral

Sevredol

MF

MP NP

C1789 C3661 C3662

P1789 P3662

20

0

 

 

 

 

 

 

MP NP

C1789 C3661 C3662

P3661

20

2

 

 

Tablet containing morphine sulfate 30 mg

Oral

Anamorph

FM

MP NP PDP

C1358

 

20

0

 

 

Tablet containing morphine sulfate 5 mg (controlled release)

Oral

MS Contin

MF

MP NP PDP

C1062

 

28

0

 

 

Tablet containing morphine sulfate 10 mg (controlled release)

Oral

Momex SR 10

SI

MP NP PDP

C1062

 

28

0

 

 

 

 

MS Contin

MF

MP NP PDP

C1062

 

28

0

 


 

 

Tablet containing morphine sulfate 15 mg (controlled release)

Oral

MS Contin

MF

MP NP PDP

C1062

 

28

0

 

 

Tablet containing morphine sulfate 30 mg (controlled release)

Oral

Momex SR 30

SI

MP NP PDP

C1062

 

28

0

 

 

 

 

MS Contin

MF

MP NP PDP

C1062

 

28

0

 

 

Tablet containing morphine sulfate 60 mg (controlled release)

Oral

Momex SR 60

SI

MP NP PDP

C1062

 

28

0

 

 

 

 

MS Contin

MF

MP NP PDP

C1062

 

28

0

 

 

Tablet containing morphine sulfate 100 mg (controlled release)

Oral

Momex SR 100

SI

MP NP PDP

C1062

 

28

0

 

 

 

 

MS Contin

MF

MP NP PDP

C1062

 

28

0

 

 

Tablet containing morphine sulfate 200 mg (controlled release)

Oral

MS Contin

MF

MP NP

C1499 C3659 C3660

P1499 P3660

28

0

 

 

 

 

 

 

MP NP

C1499 C3659 C3660

P3659

28

2

 

 

Capsule containing morphine sulfate 10 mg (containing sustained release pellets)

Oral

Kapanol

GK

MP NP PDP

C1062

 

20

0

 

 

Capsule containing morphine sulfate 20 mg (containing sustained release pellets)

Oral

Kapanol

GK

MP NP PDP

C1062

 

20

0

 

 

Capsule containing morphine sulfate 30 mg (controlled release)

Oral

MS Mono

MF

MP NP PDP

C1062

 

14

0

 

 

Capsule containing morphine sulfate 50 mg (containing sustained release pellets)

Oral

Kapanol

GK

MP NP PDP

C1062

 

20

0

 

 

Capsule containing morphine sulfate 60 mg (controlled release)

Oral

MS Mono

MF

MP NP PDP

C1062

 

14

0

 

 

Capsule containing morphine sulfate 90 mg (controlled release)

Oral

MS Mono

MF

MP NP PDP

C1062

 

14

0

 

 

Capsule containing morphine sulfate 100 mg (containing sustained release pellets)

Oral

Kapanol

GK

MP NP PDP

C1062

 

20

0

 

 

Capsule containing morphine sulfate 120 mg (controlled release)

Oral

MS Mono

MF

MP NP PDP

C1062

 

14

0

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet

Oral

MS Contin Suspension 20 mg

MF

MP NP PDP

C1062

 

28

0

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet

Oral

MS Contin Suspension 30 mg

MF

MP NP PDP

C1062

 

28

0

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet

Oral

MS Contin Suspension 60 mg

MF

MP NP PDP

C1062

 

28

0

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet

Oral

MS Contin Suspension 100 mg

MF

MP NP PDP

C1062

 

28

0

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate 200 mg per sachet

Oral

MS Contin Suspension 200 mg

MF

MP NP

C1499

 

28

0

 

 

Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL

Oral

Ordine 2

MF

MP NP PDP

C1358

 

1

0

 

 

Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL

Oral

Ordine 5

MF

MP NP PDP

C1358

 

1

0

 

 

Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL

Oral

Ordine 10

MF

MP NP PDP

C1358

 

1

0

 

 

Injection containing morphine sulfate 10 mg in 1 mL

Injection

Hospira Pty Limited

HH

MP NP MW PDP

 

 

5

0

 

 

Injection containing morphine tartrate 120 mg in 1.5 mL

Injection

Hospira Pty Limited

HH

MP NP

 

 

5

0

 

 

Injection containing morphine sulfate 15 mg in 1 mL

Injection

Hospira Pty Limited

HH

MP NP MW PDP

 

 

5

0

 

 

Injection containing morphine sulfate 30 mg in 1 mL

Injection

Hospira Pty Limited

HH

MP NP PDP

 

 

5

0

 

[19]         Schedule 1, entry for Pancreatic Extract in the form Granules (enteric coated) providing not less than 5,000 BP units of lipase activity per 100 mg, 20 g [with a Max Quantity 3 and Number of Repeats 10]

omit from the column headed “Authorised Prescriber”: MP and substitute: MP NP

[20]         Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride); and Tablet 45 mg (as hydrochloride)

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

 

 

 

Vexazone

AF

MP NP

C3540 C3541 C3542

 

28

5

 


[21]         Schedule 1, entry for Ramipril in the form Capsule 5 mg

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

 

 

 

Ramipril-GA

GM

MP NP

 

 

30

5

 

[22]         Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg

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

 

 

 

Acris Once-a-Week

AF

MP NP

C2645 C2646 C3070

 

4

5

 

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

(a)        insert in the columns in the order indicated after the first instance of the brand “Terbix 250”:

 

 

 

Tinasil

AL

MP NP

C2191 C2865 C3244

P2865 P3244

42

0

 

(b)        insert in the columns in the order indicated after the second instance of the brand “Terbix 250”:

 

 

 

Tinasil

AL

MP NP

C2191 C2865 C3244

P2191

42

1

 

[24]          Schedule 1, entry for Valaciclovir

(a)        insert in the columns in the order indicated after brand “Valaciclovir SZ”:

 

 

 

Valacor 500

RA

MP NP

C3622 C3623 C3624 C3631

P3623 P3624

30

5

 

(b)        insert in the columns in the order indicated after the third instance of the brand “Valaciclovir Sandoz”:

 

 

 

Valacor 500

RA

MP NP

C3622 C3623 C3624 C3631

P3622 P3631

42

0

 

(c)        insert in the columns in the order indicated after the fourth instance of the brand “Valtrex”:

 

 

 

Zelitrex

RE

MP

See Note 1

C1494 C3419

 

500

2

C

[25]         Schedule 3

omit:

FK

PharmaLink Pty Ltd

62 116 935 758

substitute:

FK

Invida Australia Pty Ltd

62 116 935 758

[26]         Schedule 3

omit:

GY

Mayne Pharma International Pty Ltd

88 007 870 984

[27]         Schedule 3

omit:

PD

Pfizer Australia Pty Ltd

50 008 422 348

[28]         Schedule 4, Part 1, omit entry for Copper Sulfate


[29]         Schedule 4, Part 1, entry for Levodopa with Carbidopa

insert after existing text in the columns in the order indicated:

 

 

C3703

P3703

Maintenance therapy following treatment which was commenced in a hospital-based movement disorder clinic, of a patient with advanced Parkinson disease with severe disabling motor fluctuations not adequately controlled by oral therapy.

Compliance with Authority Required procedures

 

C3704

P3704

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

Management of advanced Parkinson disease in a patient with severe disabling motor fluctuations not adequately controlled by oral therapy.
Treatment must be commenced in a hospital-based movement disorder clinic

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3704


 

C3705

P3705

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

Management of advanced Parkinson disease in a patient with severe disabling motor fluctuations not adequately controlled by oral therapy.
Treatment must be commenced in a hospital-based movement disorder clinic

Compliance with Written or Telephone Authority Required procedures

 

 

 

 

 

 

 

 

 

 

 

 

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.