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.
