PB 96 of 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.14)1
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary (Acting), 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 9 December 2011
FELICITY McNEILL
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 2011 (No. 14).
(2) This Instrument may also be cited as PB 96 of 2011.
2 Commencement
This Instrument commences on 1 January 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 Aciclovir in the form Tablet 200 mg [Max Quantity 90; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Aciclovir GH
GQ
MP NP
C3633
P3633
90
5
[2] Schedule 1, entry for Amisulpride in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Amisulpride
TX
MP NP
C1589
30
5
[3] Schedule 1, entry for Amisulpride in each of the forms: Tablet 200 mg; and Tablet 400 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Amisulpride
TX
MP NP
C1589
60
5
[4] Schedule 1, after entry for Anastrozole
insert:
Apixaban
Tablet 2.5 mg
Oral
Eliquis
BQ
MP NP
C3153 C3154
C3957
P3957
20
0
MP NP
C3153 C3154
C3957
P3154
30
0
MP NP
C3153 C3154
C3957
P3153
60
0
[5] Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Carboplatin Kabi
PK
MP
See Note 1
See Note 3
See Note 3
D
[6] Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) [Max Quantity 10; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cefaclor GH
GQ
PDP
10
0
[7] Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) [Max Quantity 10; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cefaclor GH
GQ
MP
10
1
[8] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 140 mg in 7 mL
omit from the column headed “Circumstances”:
C3893
and
C3918
insert in numerical order:
C3955 C3956
[9] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL
omit from the column headed “Circumstances”:
C3893
and
C3918
insert in numerical order:
C3955 C3956
[10] Schedule 1, entry for Docetaxel in each of the forms: Powder for I.V. infusion 20 mg with solvent; and Powder for I.V. infusion 80 mg with solvent
omit from the column headed “Circumstances”:
C3893
insert in numerical order:
C3955
[11] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL
omit from the column headed “Circumstances” (twice occurring):
C3893
and
C3918
insert in numerical order:
C3955 C3956
[12] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [DBL Docetaxel Concentrated Injection]
omit from the column headed “Circumstances”:
C3893
and
C3918
insert in numerical order:
C3955 C3956
[13] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [Docetaxel Ebewe]
omit from the column headed “Circumstances”:
C3893
insert in numerical order:
C3955
[14] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [Docetaxel Sandoz]
omit from the column headed “Circumstances”:
C3893
and
C3918
insert in numerical order:
C3955 C3956
[15] Schedule 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous)
in 0.5 mL with solvent
omit from the column headed “Circumstances”:
C3893
and
C3918
insert in numerical order:
C3955 C3956
[16] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL
omit from the column headed “Circumstances” (twice occurring):
C3893
and
C3918
insert in numerical order:
C3955 C3956
[17] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL [DBL Docetaxel Concentrated Injection]
omit from the column headed “Circumstances”:
C3893
and
C3918
insert in numerical order:
C3955 C3956
[18] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL [Docetaxel Ebewe]
omit from the column headed “Circumstances”:
C3893
insert in numerical order:
C3955
[19] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL [Docetaxel Sandoz]
omit from the column headed “Circumstances”:
C3893
and
C3918
insert in numerical order:
C3955 C3956
[20] Schedule 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
in 2 mL with solvent
omit from the column headed “Circumstances”:
C3893
and
C3918
insert in numerical order:
C3955 C3956
[21] Schedule 1, omit entry for Drotrecogin Alfa (activated)
[22] Schedule 1, after entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium) with diluent
insert in the columns in the order indicated:
Powder for I.V. infusion, 500 micrograms (as sodium) infusion administration set
Injection
Flolan Kit
GK
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
[23] Schedule 1, after entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium) with diluent
insert in the columns in the order indicated:
Powder for I.V. infusion, 1.5 mg (as sodium) infusion administration set
Injection
Flolan Kit
GK
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
[24] Schedule 1, after entry for Etravirine in the form Tablet 100 mg
insert in the columns in the order indicated:
Tablet 200 mg
Oral
Intelence
JC
MP
See Note 1
C3596 C3597
120
5
D
[25] Schedule 1, entry for Exemestane in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Exemestane
TX
MP NP
C1541 C2457
30
5
[26] Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 2.1 mg; Transdermal patch 4.2 mg; Transdermal patch 8.4 mg; Transdermal patch 12.6 mg; and Transdermal patch 16.8 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Fentanyl Sandoz
SZ
MP NP
C1062
5
0
[27] Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
(a) omit from the column headed “Responsible Person” for the brand “Fluohexal”: SZ substitute: HX
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Fluoxetine Sandoz
SZ
MP NP
C1211 C1241
28
5
[28] Schedule 1, entry for Gemcitabine
omit:
Gemcitabine
Powder for I.V. infusion 200 mg (as hydrochloride)
Injection
DBL Gemcitabine for Injection
HH
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914
See Note 3
See Note 3
D
insert in the columns in the order indicated:
Gemcitabine
Solution for injection 200 mg (as hydrochloride) in 5.3 mL
Injection
DBL Gemcitabine Injection
HH
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914
See Note 3
See Note 3
D
Powder for I.V. infusion 200 mg (as hydrochloride)
Injection
DBL Gemcitabine for Injection
HH
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914
See Note 3
See Note 3
D
[29] Schedule 1, after entry for Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL
insert in the columns in the order indicated:
Solution for injection 1 g (as hydrochloride) in 26.3 mL
Injection
DBL Gemcitabine Injection
HH
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914
See Note 3
See Note 3
D
[30] Schedule 1, after entry for Gemcitabine in the form Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL
insert in the columns in the order indicated:
Solution for injection 2 g (as hydrochloride) in 52.6 mL
Injection
DBL Gemcitabine Injection
HH
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914
See Note 3
See Note 3
D
[31] Schedule 1, entry for Glimepiride in the form Tablet 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Glimepiride 1
CR
MP NP
30
5
[32] Schedule 1, entry for Glimepiride in the form Tablet 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Glimepiride 2
CR
MP NP
30
5
[33] Schedule 1, entry for Glimepiride in the form Tablet 3 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Glimepiride 3
CR
MP NP
30
5
[34] Schedule 1, entry for Glimepiride in the form Tablet 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Glimepiride 4
CR
MP NP
30
5
[35] Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 25 (On-Call Plus)
insert in the columns in the order indicated:
Test strips, 50 (Accu-Chek Aviva)
For external use
Accu-Chek Aviva
RD
MP NP
2
5
MP
P3035
2
11
[36] Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 50 (Advantage II)
insert in the columns in the order indicated:
Test strips, 50 (AgaMatrix Jazz)
For external use
AgaMatrix Jazz
HE
MP NP
2
5
MP
P3035
2
11
[37] Schedule 1, entry for Glucose Indicator—Blood in the form Test strips, 50
omit:
Test strips, 50 (WaveSense Jazz)
For external use
WaveSense Jazz
HE
MP NP
2
5
MP
P3035
2
11
[38] Schedule 1, entry for Glucose Indicator—Blood in the form Test strips, 100 (Optium glucose)
(a) omit from the column headed “Form”: (Optium glucose) substitute: (FreeStyle Optium)
(b) omit from the column headed “Brand”: Optium glucose substitute: FreeStyle Optium
[39] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Tecan
WQ
MP
See Note 1
C3184
See Note 3
See Note 3
D
[40] Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g
omit from the column headed “Responsible Person” for the brand “your pharmacy Clear Laxative” (all instances): TW substitute: OY
[41] Schedule 1, entry for Meloxicam
omit:
Capsule 7.5 mg
Oral
Mobic
BY
MP NP
C1547 C1848
30
3
Movalis 7.5
QA
MP NP
C1547 C1848
30
3
Capsule 15 mg
Oral
Mobic
BY
MP NP
C1547 C1848
30
3
Movalis 15
QA
MP NP
C1547 C1848
30
3
substitute:
Capsule 7.5 mg
Oral
APO-Meloxicam
TX
MP NP
C1547 C1848
30
3
Chem mart Meloxicam
CH
MP NP
C1547 C1848
30
3
Mobic
BY
MP NP
C1547 C1848
30
3
Movalis 7.5
QA
MP NP
C1547 C1848
30
3
Terry White Chemists Meloxicam
TW
MP NP
C1547 C1848
30
3
Capsule 15 mg
Oral
APO-Meloxicam
TX
MP NP
C1547 C1848
30
3
Chem mart Meloxicam
CH
MP NP
C1547 C1848
30
3
Mobic
BY
MP NP
C1547 C1848
30
3
Movalis 15
QA
MP NP
C1547 C1848
30
3
Terry White Chemists Meloxicam
TW
MP NP
C1547 C1848
30
3
[42] Schedule 1, entry for Methylnaltrexone in the form Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL
omit from the column headed “Responsible Person”: PF substitute: LM
[43] Schedule 1, entry for Nicotine
substitute:
Nicotine
Transdermal patch 17.5 mg
Transdermal
Nicotinell Step 3
NC
MP NP
C3447 C3448
28
0
Transdermal patch 24.9 mg
Transdermal
Nicorette Patch
JT
MP NP
C3042 C3447 C3448
28
2
Transdermal patch 35 mg
Transdermal
Nicotinell Step 2
NC
MP NP
C3447 C3448
28
0
Transdermal patch 52.5 mg
Transdermal
Nicotinell Step 1
NC
MP NP
C3042 C3447 C3448
P3447 P3448
28
0
MP NP
C3042 C3447 C3448
P3042
28
2
Transdermal patch 114 mg
Transdermal
Nicabate P
GC
MP NP
C3042 C3447 C3448
28
2
[44] Schedule 1, entry for Omeprazole in the form Capsule 20 mg [Max Quantity 30; Number of Repeats 1]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Omeprazole
TX
MP NP
C1177 C1337 C1476 C1533
P1177
30
1
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Omeprazole Sandoz
HX
MP NP
C1177 C1337 C1476 C1533
P1177
30
1
[45] Schedule 1, entry for Omeprazole in the form Capsule 20 mg [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Omeprazole
TX
MP NP
C1177 C1337 C1476 C1533
P1337 P1476 P1533
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Omeprazole Sandoz
HX
MP NP
C1177 C1337 C1476 C1533
P1337 P1476 P1533
30
5
[46] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL
(a) omit from the column headed “Circumstances” (all instances):
C3893
and
C3918
insert in numerical order:
C3955 C3956
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Paclitaxel Pfizer
PF
MP
See Note 1
C3186 C3890 C3902 C3917 C3955 C3956
See Note 3
See Note 3
D
[47] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL
(a) omit from the column headed “Circumstances” (all instances):
C3893
and
C3918
insert in numerical order:
C3955 C3956
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Paclitaxel Pfizer
PF
MP
See Note 1
C3186 C3890 C3902 C3917 C3955 C3956
See Note 3
See Note 3
D
[48] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL
omit from the column headed “Circumstances” (all instances):
C3893
and
C3918
insert in numerical order:
C3955 C3956
[49] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL
(a) omit from the column headed “Circumstances” (all instances):
C3893
and
C3918
insert in numerical order:
C3955 C3956
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Paclitaxel Pfizer
PF
MP
See Note 1
C3186 C3890 C3902 C3917 C3955 C3956
See Note 3
See Note 3
D
[50] Schedule 1, entry for Paclitaxel, nanoparticle albumin-bound
omit from the column headed “Circumstances”:
C3897
substitute:
C3955 C3956
[51] Schedule 1, entry for Paracetamol in the form Tablet 500 mg
(a) omit from the column headed “Responsible Person” for the brand “Chem mart Paracetamol” (all instances): YM substitute: XS
(b) omit from the column headed “Responsible Person” for the brand “Terry White Chemists Paracetamol” (all instances): YM substitute: YS
[52] Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as mesilate)
omit from the column headed “Responsible Person” for the brand “Pharmacor Paroxo 20”: CR substitute: MI
[53] Schedule 1, omit entry for Peginterferon Alfa-2b
[54] Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril/Indapamide GH 4/1.25
GQ
MP NP
C3307
30
5
[55] Schedule 1, entry for Phenoxybenzamine in the form Capsules containing phenoxybenzamine hydrochloride 10 mg, 100
omit from the column headed “Responsible Person”: GH substitute: BZ
[56] 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”:
Pioglitazone-GA
GM
MP NP
C3540 C3541 C3542
28
5
[57] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Pravastat 10
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit from the column headed “Responsible Person” for the brand “Pravastatin 10”: CR substitute: MI
[58] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Pravastat 10
CR
MP
C1540 C3047
P3047
30
11
(b) omit from the column headed “Responsible Person” for the brand “Pravastatin 10”: CR substitute: MI
[59] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Pravastat 20
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit from the column headed “Responsible Person” for the brand “Pravastatin 20”: CR substitute: MI
[60] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Pravastat 20
CR
MP
C1540 C3047
P3047
30
11
(b) omit from the column headed “Responsible Person” for the brand “Pravastatin 20”: CR substitute: MI
[61] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Pravastat 40
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit from the column headed “Responsible Person” for the brand “Pravastatin 40”: CR substitute: MI
[62] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Pravastat 40
CR
MP
C1540 C3047
P3047
30
11
(b) omit from the column headed “Responsible Person” for the brand “Pravastatin 40”: CR substitute: MI
[63] Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Prozine 5
CR
PDP MP NP
25
0
[64] Schedule 1, entry for Romiplostin
omit from the column headed “Listed Drug”: Romiplostin substitute: Romiplostim
[65] Schedule 1, entry for Simvastatin in the form Tablet 5 mg
(a) omit:
Simvasyn
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit:
Simvasyn
CR
MP
C1540 C3047
P3047
30
11
[66] Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvacor 10
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit:
Simvasyn
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[67] Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvacor 10
CR
MP
C1540 C3047
P3047
30
11
(b) omit:
Simvasyn
CR
MP
C1540 C3047
P3047
30
11
[68] Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvacor 20
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit:
Simvasyn
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[69] Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvacor 20
CR
MP
C1540 C3047
P3047
30
11
(b) omit:
Simvasyn
CR
MP
C1540 C3047
P3047
30
11
[70] Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvacor 40
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit:
Simvasyn
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[71] Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvacor 40
CR
MP
C1540 C3047
P3047
30
11
(b) omit:
Simvasyn
CR
MP
C1540 C3047
P3047
30
11
[72] Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvacor 80
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit from the column headed “Responsible Person” for the brand “Simvahexal”: SZ substitute: HX
(c) 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
(d) omit:
Simvasyn
CR
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[73] Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvacor 80
CR
MP
C1540 C3047
P3047
30
11
(b) omit from the column headed “Responsible Person” for the brand “Simvahexal”: SZ substitute: HX
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvastatin Sandoz
CR
MP
C1540 C3047
P3047
30
11
(d) omit:
Simvasyn
CR
MP
C1540 C3047
P3047
30
11
[74] Schedule 1, entry for Tacrolimus in the form Capsule 500 micrograms
omit from the column headed “Form”: Capsule 500 micrograms substitute: Capsule 0.5 mg
[75] Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)
omit from the column headed “Brand” (twice occurring): Lamisil substitute: Lamisil (Novartis Pharmaceuticals Australia Pty Limited)
[76] Schedule 1, entry for Testosterone
omit:
Injection containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate, 100 mg testosterone decanoate) in 1 mL
Injection
Sustanon 250
MK
MP
C1021 C1022 C1226
3
3
[77] Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Valacor 500” (twice occurring): RA substitute: QR
[78] Schedule 3, after details relevant to Responsible person code BY
insert:
BZ
Boucher & Muir Pty Ltd
58 000 140 474
[79] Schedule 3, after details relevant to Responsible person code ON
insert:
OY
Orion Laboratories Pty Ltd
56 009 293 136
[80] Schedule 3, after details relevant to Responsible person code QB
insert:
QR
Ranbaxy Australia Pty Limited
17 110 871 826
[81] Schedule 3, after details relevant to Responsible person code XF
insert:
XS
Symbion Pty Ltd
25 000 875 034
[82] Schedule 3, details relevant to Responsible person code YM
omit: Symbion Pharmacy Services Pty Ltd substitute: Symbion Pty Ltd
[83] Schedule 3, after details relevant to Responsible person code YN
insert:
YS
Symbion Pty Ltd
25 000 875 034
[84] Schedule 4, Part 1, after entry for Anastrozole
insert:
Apixaban
C3153
P3153
Prevention of venous thromboembolism in a patient undergoing total hip replacement
Compliance with Authority Required procedures
C3154
P3154
Prevention of venous thromboembolism in a patient undergoing total knee replacement
Compliance with Authority Required procedures
C3957
P3957
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy
Compliance with Authority Required procedures
[85] Schedule 4, Part 1, entry for Docetaxel
(a) omit:
C3893
Advanced breast cancer after failure of prior therapy
Compliance with Authority Required procedures - Streamlined Authority Code 3893
(b) omit:
C3918
Treatment of HER2 positive early breast cancer in combination with trastuzumab
Compliance with Authority Required procedures - Streamlined Authority Code 3918
(c) insert after existing text in the columns in the order indicated:
C3955
Metastatic breast cancer
Compliance with Authority Required procedures - Streamlined Authority Code 3955
C3956
Treatment of HER2 positive breast cancer in combination with trastuzumab
Compliance with Authority Required procedures - Streamlined Authority Code 3956
[86] Schedule 4, Part 1, omit entry for Drotrecogin Alfa (activated)
[87] Schedule 4, Part 1, entry for Nicotine
(a) insert in the column headed “Purposes” for the circumstances code “C3042”: P3042
(b) insert in the column headed “Purposes” for the circumstances code “C3447”: P3447
(c) insert in the column headed “Purposes” for the circumstances code “C3448”: P3448
[88] Schedule 4, Part 1, entry for Paclitaxel
(a) omit:
C3893
Advanced breast cancer after failure of prior therapy
Compliance with Authority Required procedures - Streamlined Authority Code 3893
(b) omit:
C3918
Treatment of HER2 positive early breast cancer in combination with trastuzumab
Compliance with Authority Required procedures - Streamlined Authority Code 3918
(c) insert after existing text in the columns in the order indicated:
C3955
Metastatic breast cancer
Compliance with Authority Required procedures - Streamlined Authority Code 3955
C3956
Treatment of HER2 positive breast cancer in combination with trastuzumab
Compliance with Authority Required procedures - Streamlined Authority Code 3956
[89] Schedule 4, Part 1, entry for Paclitaxel, nanoparticle albumin-bound
(a) omit from the column headed “Circumstances Code”: C3897 substitute C3955
(b) omit from the column headed “Circumstances and Purposes”: after failure of prior therapy
(c) omit from the column headed “Authority Requirements”: 3897 substitute 3955
(d) insert after existing text in the columns in the order indicated:
C3956
Treatment of HER2 positive breast cancer in combination with trastuzumab
Compliance with Authority Required procedures - Streamlined Authority Code 3956
[90] Schedule 4, Part 1, omit entry for Peginterferon Alfa-2b
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.
