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.
