National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 5) (No. PB 31 of 2011) (Cth)

Case

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
  1. 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
  1. 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
  1. 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
  1. 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
  1. 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
  1. Schedule 1, entry for Lisinopril in the form Tablet 10 mg

omit:

Lisinopril Hexal HX MP NP 30 5
  1. Schedule 1, entry for Mefenamic Acid

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

  1. 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
  1. 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
  1. 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
  1. 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

  1. 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
  1. 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
  1. 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
  1. 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
  1. 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
  1. Schedule 3

omit:

FK PharmaLink Pty Ltd 62 116 935 758

substitute:

FK Invida Australia Pty Ltd 62 116 935 758
  1. Schedule 3

omit:

GY Mayne Pharma International Pty Ltd 88 007 870 984
  1. Schedule 3

omit:

PD Pfizer Australia Pty Ltd 50 008 422 348
  1. Schedule 4, Part 1, omit entry for Copper Sulfate

  1. 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.

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