National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 12) (No. PB 83 of 2011) (Australia)

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 12) (No. PB 83 of 2011)

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PB 83 of 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.12)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 22 November 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. 12).
            (2)        This Instrument may also be cited as PB 83 of 2011.
2          Commencement
            This Instrument commences on 1 December 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]           Subsections 5(2), 5(3) and 5(4), and notes to 5(2) and 5(4)
substitute
(2)        For subparagraph 85(2)(b)(i) of the Act, paragraph 85(2)(b) of the Act applies to a listed drug mentioned in subparagraph (1)(a)(ii).
(3)        For subparagraph 85(2)(b)(ii) of the Act, paragraph 85(2)(b) of the Act applies to an additive mentioned in Part 2 of Schedule 2.
            Note           Part VII of the Act applies to medicinal preparations composed of 1 or more listed drugs mentioned in subsection (2) and 1 or more of the additives mentioned in subsection (3) – see paragraph 85(2)(b) of the Act.
[2]           Subsection 20(1), and note to subsection 20(1)
substitute:
(1)        For subsection 85 (2A) of the Act, if the letter D is mentioned in the column headed ‘Section 100 only’ in Schedule 1 for a listed drug, the drug can only be supplied under special arrangements under section 100 of the Act.

[3]           Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)
omit from the column headed “Circumstances” (all instances):
C2645
insert in numerical order:
C3933
[4]           Schedule 1, entry for Alendronic acid with colecalciferol
omit from the column headed “Circumstances” (all instances):
C2645
insert in numerical order:
C3933
[5]           Schedule 1, entry for Alendronic acid with colecalciferol and calcium
omit from the column headed “Circumstances” (twice occurring):
C2645
insert in numerical order:
C3933
[6]           Schedule 1, entry for Arsenic
substitute:
Arsenic
Injection concentrate containing arsenic trioxide 10 mg in 10 mL
Injection
Phenasen
PL
MP
See Note 1
C3150 C3891

See Note 3
See Note 3
D
[7]           Schedule 1, after entry for Artemether with lumefantrine in the form Tablet (dispersible) 20 mg-120 mg
insert:
Asenapine
Sublingual wafer 5 mg (as maleate)
Sublingual
Saphris
LU
MP NP
C1589 C3935 C3936

60
5

Sublingual wafer 10 mg (as maleate)
Sublingual
Saphris
LU
MP NP
C1589 C3935 C3936

60
5

[8]           Schedule 1, entry for Bevacizumab
substitute:
Bevacizumab
Solution for I.V. infusion 100 mg in 4 mL
Injection
Avastin
RO
MP
See Note 1
C3430 C3431 C3894 C3896

See Note 3
See Note 3
D

Solution for I.V. infusion 400 mg in 16 mL
Injection
Avastin
RO
MP
See Note 1
C3430 C3431 C3894 C3896

See Note 3
See Note 3
D

[9]           Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Bisoprolol GH
GQ
MP NP
C3234

28
5

[10]         Schedule 1, entry for Bleomycin
substitute:
Bleomycin
Powder for injection containing bleomycin sulfate 15,000 I.U.
Injection
Hospira Pty Limited
HH
MP
See Note 1
C1139 C1198

See Note 3
See Note 3
D
[11]         Schedule 1, entry for Bortezomib
substitute:
Bortezomib
Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent)
Injection
Velcade
JC
MP
See Note 1
C3762 C3763 C3764 C3765 C3766 C3767
P3764 P3767 See Note 2
4
See Note 2
2
See Note 2

MP
See Note 1
C3762 C3763 C3764 C3765 C3766 C3767
P3762 P3763 P3765 P3766
See Note 2
4
See Note 2
3
See Note 2

[12]         Schedule 1, entry for Botulinum Toxin Type Apurified Neurotoxin Complex
substitute:
Botulinum Toxin Type A Purified Neurotoxin Complex
Lyophilised powder for injection 100 units
Injection
Botox
AG
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
[13]         Schedule 1, entry for Budesonide with Eformoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2
insert in numerical order in the column headed “Circumstances”:
C2680
[14]         Schedule 1, entry for Capecitabine
omit from the column headed “Circumstances” (twice occurring):
C2267
insert in numerical order:
C3942
[15]         Schedule 1, entry for Captopril in each of the forms: Tablet 25 mg; and Tablet 50 mg
omit:

Ascent Pharma Pty Ltd
GM
MP NP

90
5

[16]         Schedule 1, entry for Carboplatin
substitute:
Carboplatin
Solution for I.V. injection 50 mg in 5 mL
Injection
Carboplatin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D

Solution for I.V. injection 150 mg in 15 mL
Injection
Carboplatin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D

Solution for I.V. injection 450 mg in 45 mL
Injection
Carboplatin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D

[17]         Schedule 1, entry for Cetuximab
substitute:
Cetuximab
Solution for I.V. infusion 100 mg in 20 mL
Injection
Erbitux
SG
MP
See Note 1
C2713 C2714 C2715 C3843 C3844 C3903 C3904 C3919 C3920 C3921
See Note 3
See Note 3
See Note 3
D

Solution for I.V. infusion 500 mg in 100 mL
Injection
Erbitux
SG
MP
See Note 1
C2713 C2714 C2715 C3843 C3844 C3903 C3904 C3919 C3920 C3921
See Note 3
See Note 3
See Note 3
D

[18]         Schedule 1, entry for Cisplatin
substitute:
Cisplatin
I.V. injection 10 mg in 10 mL
Injection
Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D

I.V. injection 50 mg in 50 mL
Injection
Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D

I.V. injection 100 mg in 100 mL
Injection
Cisplatin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D

[19]         Schedule 1, entry for Cladribine
substitute:
Cladribine
Injection 10 mg in 5 mL
Injection
Litak
OA
MP
See Note 1
C3180

See Note 3
See Note 3
D

Solution for I.V. infusion 10 mg in 10 mL single use vial
Injection
Leustatin
JC
MP
See Note 1
C3180

See Note 3
See Note 3
D

[20]         Schedule 1, entry for Codeine with Paracetamol
(a)        omit:

Dolaforte
CO
MP NP PDP

20
0

(b)        omit:

Dolaforte
CO
MP NP

P2064
60
0

[21]         Schedule 1, after entry for Colestipol
insert in the columns in the order indicated:
Corifollitropin Alfa
Solution for injection 100 micrograms in 0.5 mL single dose pre-filled syringe
Injection
Elonva
MK
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

Solution for injection 150 micrograms in 0.5 mL single dose pre-filled syringe
Injection
Elonva
MK
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

[22]         Schedule 1, entry for Cyclophosphamide
substitute:
Cyclophosphamide
Tablet 50 mg
Oral
Cycloblastin
PF
MP

50
2

Powder for injection 500 mg (anhydrous)
Injection
Endoxan
BX
MP
See Note 1

See Note 3
See Note 3
PB

Powder for injection 1 g (anhydrous)
Injection
Endoxan
BX
MP
See Note 1

See Note 3
See Note 3
PB

Powder for injection 2 g (anhydrous)
Injection
Endoxan
BX
MP
See Note 1

See Note 3
See Note 3
PB

[23]         Schedule 1, entry for Cytarabine
substitute:
Cytarabine
Injection 100 mg in 5 mL vial
Injection
Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D
[24]         Schedule 1, entry for Dalteparin
omit:

Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe
Injection
Fragmin
PF
MP NP

10
1

MP NP

P1148
20
3

Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe
Injection
Fragmin
PF
MP NP

10
1

Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe
Injection
Fragmin
PF
MP NP

10
1

substitute:

Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe
Injection
Fragmin
PF
MP NP

10
1

MP NP

P1148
20
3

P3688
30
5

Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe
Injection
Fragmin
PF
MP NP

10
1

P3688
30
5

Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe
Injection
Fragmin
PF
MP NP

10
1

P3688
30
5

Injection containing dalteparin sodium 15,000 I.U. (anti-Xa) in 0.6 mL single dose pre-filled syringe
Injection
Fragmin
PF
MP NP
C3688

30
5

Injection containing dalteparin sodium 18,000 I.U. (anti-Xa) in 0.72 mL single dose pre-filled syringe
Injection
Fragmin
PF
MP NP
C3688

30
5

[25]         Schedule 1, after entry for Darunavir in the form Tablet 300 mg (as ethanolate)
insert in the columns in the order indicated:

Tablet 400 mg (as ethanolate)
Oral
Prezista
JC
MP
See Note 1
C3940 C3941

120
5
D
[26]         Schedule 1, after entry for Denosumab in the form Injection 60 mg in 1 mL pre-filled syringe
insert in the columns in the order indicated:

Injection 120 mg in 1.7 mL
Injection
Xgeva
AN
MP NP
C1035 C3881

1
5

[27]         Schedule 1, entry for Dexamethasone in the form Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dexmethsone
AS
MP NP

5
0

[28]         Schedule 1, entry for Dexamethasone in the form Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dexmethsone
AS
MP NP

5
1

[29]         Schedule 1, entry for Diltiazem in each of the forms: Capsule (controlled delivery) containing diltiazem hydrochoride 180 mg; and
Capsule (controlled delivery) containing diltiazem hydrochoride 240 mg
omit:

Dilzem CD
GM
MP NP

30
5

[30]         Schedule 1, entry for Docetaxel
substitute:

Docetaxel
Solution concentrate for I.V. infusion 140 mg in 7 mL
Injection
Oncotaxel 140
TA
MP
See Note 1
C3186 C3884 C3888 C3890 C3892 C3893 C3916 C3918

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 160 mg in 16 mL
Injection
DBL Docetaxel Concentrated Injection
HH
MP
See Note 1
C3186 C3884 C3888 C3890 C3893 C3916 C3918

See Note 3
See Note 3
D

Powder for I.V. infusion 20 mg with solvent
Injection
Docetaxel SUN
ZF
MP
See Note 1
C3186 C3884 C3890 C3893

See Note 3
See Note 3
D

Powder for I.V. infusion 80 mg with solvent
Injection
Docetaxel SUN
ZF
MP
See Note 1
C3186 C3884 C3890 C3893

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 20 mg in 1 mL
Injection
Oncotaxel 20
TA
MP
See Note 1
C3186 C3884 C3888 C3890 C3892 C3893 C3916 C3918
See Note 3
See Note 3
See Note 3
D

Taxotere
SW
MP
See Note 1
C3186 C3884 C3888 C3890 C3892 C3893 C3916 C3918
See Note 3
See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 20 mg in 2 mL
Injection
DBL Docetaxel Concentrated Injection
HH
MP
See Note 1
C3186 C3884 C3888 C3890 C3893 C3916 C3918
See Note 3
See Note 3
See Note 3
D

Docetaxel Ebewe
HX
MP
See Note 1
C3186 C3884 C3888 C3890 C3893 C3916
See Note 3
See Note 3
See Note 3
D

Docetaxel Sandoz
SZ
MP
See Note 1
C3186 C3884 C3888 C3890 C3893 C3916 C3918
See Note 3
See Note 3
See Note 3
D

Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent
Injection
Taxotere
SW
MP
See Note 1
C3186 C3884 C3888 C3890 C3892 C3893 C3916 C3918
See Note 3
See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 80 mg in 4 mL
Injection
Oncotaxel 80
TA
MP
See Note 1
C3186 C3884 C3888 C3890 C3892 C3893 C3916 C3918

See Note 3
See Note 3
D

Taxotere
SW
MP
See Note 1
C3186 C3884 C3888 C3890 C3892 C3893 C3916 C3918

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 80 mg in 8 mL
Injection
DBL Docetaxel Concentrated Injection
HH
MP
See Note 1
C3186 C3884 C3888 C3890 C3893 C3916 C3918

See Note 3
See Note 3
D

Docetaxel Ebewe
HX
MP
See Note 1
C3186 C3884 C3888 C3890 C3893 C3916

See Note 3
See Note 3
D

Docetaxel Sandoz
SZ
MP
See Note 1
C3186 C3884 C3888 C3890 C3893 C3916 C3918

See Note 3
See Note 3
D

Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent
Injection
Taxotere
SW
MP
See Note 1
C3186 C3884 C3888 C3890 C3892 C3893 C3916 C3918

See Note 3
See Note 3
D

[31]         Schedule 1, entry for Doxorubicin
substitute:

Doxorubicin
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial
Injection/ intravesical
Adriamycin Solution
PF
MP
See Note 1

See Note 3
See Note 3
D

Doxorubicin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

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 1

See Note 3
See Note 3
D

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial
Injection/ intravesical
Adriamycin Solution
PF
MP
See Note 1

See Note 3
See Note 3
D

Doxorubicin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial
Injection/ intravesical
Doxorubicin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
Injection/ intravesical
Adriamycin
PF
MP
See Note 1

See Note 3
See Note 3
D

Doxorubicin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

[32]         Schedule 1, entry for Doxorubicin ─ Pegylated Liposomal
substitute:
Doxorubicin – Pegylated Liposomal
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
Injection
Caelyx
JC
MP
See Note 1
C1568 C1795 C1796 C3905 C3910 C3911

See Note 3
See Note 3
D

MP
See Note 1

C1828 C1829 C3348 C3349

4
5
D

Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL
Injection
Caelyx
JC
MP
See Note 1
C1568 C1795 C1796 C3905 C3910 C3911

See Note 3
See Note 3
D

[33]         Schedule 1, entry for Epirubicin
substitute:
Epirubicin
Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL
Injection/
intravesical
Epirubicin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Pharmorubicin Solution
PF
MP
See Note 1

See Note 3
See Note 3
D

Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL
Injection/
intravesical
Pharmorubicin Solution
PF
MP
See Note 1

See Note 3
See Note 3
D

Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
Injection/
intravesical
Epirubicin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

Pharmorubicin Solution
PF
MP
See Note 1

See Note 3
See Note 3
D

Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL
Injection/
intravesical
Epirubicin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
Injection/
intravesical
DBL Epirubicin Hydrochloride Injection
HH
MP
See Note 1

See Note 3
See Note 3
D

Epirubicin Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

[34]         Schedule 1, entry for Etoposide
substitute:
Etoposide
Capsule 50 mg
Oral
Vepesid
BQ
MP

20

0

Capsule 100 mg
Oral
Vepesid
BQ
MP

10

0

Solution for I.V. infusion 100 mg in 5 mL vial
Injection
Etoposide Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
PB

Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
PB

Powder for I.V. infusion 100 mg (as phosphate)
Injection
Etopophos
BQ
MP
See Note 1

See Note 3
See Note 3
PB

Powder for I.V. infusion 1 g (as phosphate)
Injection
Etopophos
BQ
MP
See Note 1

See Note 3
See Note 3
PB

[35]         Schedule 1, entry for Famciclovir
omit:

Tablet 500 mg
Oral
Famvir
NV
MP NP
C3625 C3626 C3627 C3628 C3629
P3625
30
0

Favic 500
QA
MP NP
C3625 C3626 C3627 C3628 C3629
P3625
30
0

Ezovir
AF
MP NP
C3625 C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5

Famvir
NV
MP NP
C3625 C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5

Favic 500
QA
MP NP
C3625 C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5

substitute:

Tablet 500 mg
Oral
APO-Famciclovir
TX
MP NP
C3625 C3626 C3627 C3628 C3629
P3625
30
0

Chem mart Famciclovir
CH
MP NP
C3625 C3626 C3627 C3628 C3629
P3625
30
0

Famvir
NV
MP NP
C3625 C3626 C3627 C3628 C3629
P3625
30
0

Favic 500
QA
MP NP
C3625 C3626 C3627 C3628 C3629
P3625
30
0

Terry White Chemists Famciclovir
TW
MP NP
C3625 C3626 C3627 C3628 C3629
P3625
30
0

APO-Famciclovir
TX
MP NP
C3625 C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5

Chem mart Famciclovir
CH
MP NP
C3625 C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5

Ezovir
AF
MP NP
C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5

Famvir
NV
MP NP
C3625 C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5

Favic 500
QA
MP NP
C3625 C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5

Terry White Chemists Famciclovir
TW
MP NP
C3625 C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5

[36]         Schedule 1, entry for Fludarabine
substitute:
Fludarabine
Tablet containing fludarabine phosphate 10 mg
Oral
Fludara
GZ
MP
C3015

20
5

Powder for I.V. injection containing fludarabine phosphate 50 mg
Injection
Farine
WQ
MP
See Note 1
C3887

See Note 3
See Note 3
PB

Fludara
GZ
MP
See Note 1
C3887

See Note 3
See Note 3
PB

Fludarabine Actavis
TA
MP
See Note 1
C3887

See Note 3
See Note 3
PB

Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL
Injection
Fludarabine Ebewe
SZ
MP
See Note 1
C3887

See Note 3
See Note 3
PB

[37]         Schedule 1, entry for Fluorouracil
substitute:
Fluorouracil
Injection 500 mg in 10 mL
Injection
Fluorouracil Ebewe
SZ
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

Injection 1000 mg in 20 mL
Injection
DBL Fluorouracil Injection BP
HH
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

Fluorouracil Ebewe
SZ
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

Injection 2500 mg in 50 mL
Injection
DBL Fluorouracil Injection BP
HH
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

Fluorouracil Ebewe
SZ
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

Injection 5000 mg in 100 mL
Injection
Fluorouracil Ebewe
SZ
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

[38]         Schedule 1, entry for Fotemustine
substitute:
Fotemustine
Powder for injection 208 mg with solvent
Injection
Muphoran
SE
MP
See Note 1
C3181

See Note 3
See Note 3
D
[39]         Schedule 1, entry for Ganirelix
omit (second instance):

Orgalutran
MK
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
[40]         Schedule 1, entry for Gemcitabine
substitute:

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

Gemcitabine Actavis
TA
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemcitabine Ebewe
SZ
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemcitabine Kabi
PK
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemcitabine Sun
ZF
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemcite
ZP
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemplan
WQ
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemzar
LY
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL
Injection
Gemcitabine Ebewe
SZ
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL
Injection
Gemcitabine Ebewe
SZ
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 1 g (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

Gemcitabine Actavis
TA
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemcitabine Ebewe
SZ
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemcitabine Kabi
PK
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemcitabine Sun
ZF
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemcite
ZP
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemplan
WQ
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Gemzar
LY
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL
Injection
Gemcitabine Ebewe
SZ
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 2 g (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

Gemcitabine Kabi
PK
MP
See Note 1
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

See Note 3
See Note 3
D

[41]         Schedule 1, entry for Idarubicin
substitute:
Idarubicin
Capsule containing idarubicin hydrochloride 5 mg
Oral
Zavedos
PF
MP

C1006

3
0

Capsule containing idarubicin hydrochloride 10 mg
Oral
Zavedos
PF
MP

C1006

3
0

Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL
Injection
Idarubicin Ebewe
SZ
MP
See Note 1
C1006

See Note 3
See Note 3
PB

Zavedos Solution
PF
MP
See Note 1
C1006

See Note 3
See Note 3
PB

Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL
Injection
Idarubicin Ebewe
SZ
MP
See Note 1
C1006

See Note 3
See Note 3
PB

Zavedos Solution
PF
MP
See Note 1
C1006

See Note 3
See Note 3
PB

[42]         Schedule 1, entry for Ifosfamide
substitute:
Ifosfamide
Powder for I.V. injection 1 g in single dose vial
Injection
Holoxan
BX
MP
See Note 1
C1325 C1327

See Note 3
See Note 3
D

Powder for I.V. injection 2 g in single dose vial
Injection
Holoxan
BX
MP
See Note 1
C1325 C1327

See Note 3
See Note 3
D

[43]         Schedule 1, after entry for Imiquimod
insert:
Indacaterol
Capsule containing powder for oral inhalation 150 micrograms (as maleate) (for use in Breezhaler)
Inhalation by mouth
Onbrez
NV
MP NP
C3883

30
5

Capsule containing powder for oral inhalation 300 micrograms (as maleate) (for use in Breezhaler)
Inhalation by mouth
Onbrez
NV
MP NP
C3883

30
5

[44]         Schedule 1, entry for Interferon Alfa-2a
substitute:
Interferon Alfa-2a
Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
Roferon-A
RO
MP
See Note 1
C1149 C1196 C1234 C3180 C3895 C3899
P1149 P1234
P3180 P3899
15

4

MP
See Note 1
C1149 C1196 C1234 C3180 C3895 C3899
P1196 P3895

15

5

MP
See Note 1
C1463 C3382 C3869 C3870

30
5

C

Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
Roferon-A
RO
MP
See Note 1
C1196 C1234 C3895 C3899
P1234 P3899

5

4

MP
See Note 1
C1196 C1234 C3895 C3899
P1196 P3895
5
5

MP
See Note 1
C1463 C3382 C3869 C3870

30
5
C

Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
Roferon-A
RO
MP
See Note 1
C1196 C1234 C3895 C3899
P1234 P3899
5
4

MP
See Note 1
C1196 C1234 C3895 C3899
P1196 P3895
5
5

MP
See Note 1
C1463 C3382 C3869 C3870

30

5
C

Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
Roferon-A
RO
MP
See Note 1
C1196 C1234 C3895 C3899
P1234 P3899
5
4

MP
See Note 1
C1196 C1234 C3895 C3899
P1196 P3895
5
5

MP
See Note 1
C1463 C3382 C3869 C3870

30
5
C

[45]         Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 18,000,000 I.U.in 1.2 mL multi-dose injection pen
omit:

MP
See Note 1
C1149 C1196 C1206
P1149
3
4

MP
See Note 1
C1149 C1196 C1206
P1196 P1206
3
5

substitute:

MP
See Note 1
C1149 C1196 C1206 C3180 C3895 C3898
P1149 P3180
3
4

MP
See Note 1
C1149 C1196 C1206 C3180 C3895 C3898
P1196 P1206 P3895 P3898
3
5

[46]         Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen
omit:

MP
See Note 1
C1196 C1206

3
5

substitute:

MP
See Note 1
C1196 C1206 C3895 C3898

3
5

[47]         Schedule 1, entry for Irinotecan
substitute:

Irinotecan
I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
Injection
Camptosar
PF
MP
See Note 1
C3184

See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Actavis
TA
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Alphapharm
AF
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Ebewe
SZ
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Kabi
PK
MP
See Note 1
C3184

See Note 3
See Note 3
D

Omegapharm Irinotecan
OE
MP
See Note 1
C3184

See Note 3
See Note 3
D

Tecan
WQ
MP
See Note 1
C3184

See Note 3
See Note 3
D

I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
Injection
Camptosar
PF
MP
See Note 1
C3184

See Note 3
See Note 3
D

Hospira Pty Limited
HH
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Actavis
TA
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Alphapharm
AF
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Ebewe
SZ
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Kabi
PK
MP
See Note 1
C3184

See Note 3
See Note 3
D

Omegapharm Irinotecan
OE
MP
See Note 1
C3184

See Note 3
See Note 3
D

Tecan
WQ
MP
See Note 1
C3184

See Note 3
See Note 3
D

I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL
Injection
Camptosar
PF
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Ebewe
SZ
MP
See Note 1
C3184

See Note 3
See Note 3
D

I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
Injection
Hospira Pty Limited
HH
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Actavis 500
TA
MP
See Note 1
C3184

See Note 3
See Note 3
D

Irinotecan Ebewe
SZ
MP
See Note 1
C3184

See Note 3
See Note 3
D

[48]         Schedule 1, entry for Lacosamide
omit:

Oral solution 15 mg per mL, 200 mL
Oral
Vimpat
UC
MP NP
C3303 C3304

2
5

[49]         Schedule 1, after entry for Lopinavir with Ritonavir
insert:
Losartan
Tablet containing losartan potassium 25 mg
Oral
Cozavan
AF
MP NP

30
5

Tablet containing losartan potassium 50 mg
Oral
Cozavan
AF
MP NP

60
5

[50]         Schedule 1, after entry for Macrogol 3350 in the form Powder for oral solution 510 g [your pharmacy Clear Laxative (third instance)]
insert:
Magnesium
Tablet 37.4 mg (as aspartate dihydrate)
Oral
Mag-Sup
PP
MP NP
C3937 C3938

50
5

[51]         Schedule 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 10 mg
(a)        omit from the column headed “Responsible Person”:                 SZ          substitute:             HX
(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Medroxyprogesterone Sandoz
SZ
MP NP

30
2

[52]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
omit:

Glucohexal
HX
MP NP

100
5

[53]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit:

Glucohexal
HX
MP NP

60
5

[54]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
omit:

Glucohexal
HX
MP NP

90
5

[55]         Schedule 1, entry for Methotrexate
substitute:
Methotrexate
Tablet 2.5 mg
Oral
Hospira Pty Limited
HH
MP

30
5

Methoblastin
PF
MP

30
5

Tablet 10 mg
Oral
Methoblastin
PF
MP

15
3

MP

P2884
50
2

Injection 5 mg in 2 mL vial
Injection
Hospira Pty Limited
HH
MP
See Note 1

See Note 2
5
See Note 2
0
See Note 2

Injection 50 mg in 2 mL vial
Injection
Hospira Pty Limited
HH
MP
See Note 1

See Note 2
5
See Note 2
5
See Note 2

Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 2
5
See Note 2
5
See Note 2

Solution concentrate for I.V. infusion 500 mg in 20 mL vial
Injection
Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
See Note 3
PB

Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
Injection
Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
See Note 3
PB

Methotrexate Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
See Note 3
PB

Solution concentrate for I.V. infusion 5000 mg in 50 mL vial
Injection
Methotrexate Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
See Note 3
PB

[56]         Schedule 1, entry for Mitozantrone
substitute:
Mitozantrone
Injection 10 mg (as hydrochloride) in 5 mL
Injection
Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D

Injection 20 mg (as hydrochloride) in 10 mL
Injection
Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

Mitozantrone Ebewe
SZ
MP
See Note 1

See Note 3
See Note 3
D

Onkotrone
BX
MP
See Note 1

See Note 3
See Note 3
D

Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D

Injection 25 mg (as hydrochloride) in 12.5 mL
Injection
Onkotrone
BX
MP
See Note 1

See Note 3
See Note 3
D

Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D

[57]         Schedule 1, entry for Morphine in each of the forms: Tablet containing morphine sulfate 10 mg (controlled release); Tablet containing morphine sulfate 30 mg (controlled release); Tablet containing morphine sulfate 60 mg (controlled release); and Tablet containing morphine sulfate 100 mg (controlled release)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APOTEX-MORPHINE MR
TX
MP NP
C1062

28
0

[58]         Schedule 1, entry for Nafarelin
substitute:
Nafarelin
Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses
Nasal
Synarel
PF
MP
See Note 1
C1172 C1389
See Note 2
See Note 2
1
See Note 2
5
See Note 2

[59]         Schedule 1, entry for Norethisterone with Ethinyloestradiol in the form Pack containing 12 tablets 500 micrograms-35 micrograms,
9 tablets 1 mg-35 micrograms and 7 inert tablets
omit:

Synphasic
PF
MP NP

4
2

[60]         Schedule 1, entry for Norethisterone with Mestranol
substitute:
Norethisterone with Mestranol
Pack containing 21 tablets 1 mg-50 micrograms and 7 inert tablets
Oral
Norinyl-1/28
PF
MP NP

4
2

[61]         Schedule 1, entry for Oxaliplatin
substitute:

Oxaliplatin
Solution concentrate for I.V. infusion 50 mg in 10 mL
Injection
DBL Oxaliplatin Concentrate
HH
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Eloxatin
SW
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin Kabi
PK
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin SUN
ZF
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Powder for I.V. infusion 50 mg
Injection
Hospira Pty Limited
HH
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxalatin
ZP
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin Actavis
TA
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin Alphapharm
AF
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin Ebewe
SZ
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin Link
PK
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Xalox
WQ
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 100 mg in 20 mL
Injection
DBL Oxaliplatin Concentrate
HH
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Eloxatin
SW
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin Kabi
PK
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin SUN
ZF
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Powder for I.V. infusion 100 mg
Injection
Hospira Pty Limited
HH
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxalatin
ZP
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin Actavis
TA
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin Alphapharm
AF
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin Ebewe
SZ
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin Link
PK
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Winthrop Oxaliplatin
WA
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Xalox
WQ
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 200 mg in 40 mL
Injection
Eloxatin
SW
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

Oxaliplatin SUN
ZF
MP
See Note 1
C3900 C3901 C3930 C3939

See Note 3
See Note 3
D

[62]         Schedule 1, after entry for Oxycodone in the form Suppository 30 mg (as pectinate)
insert:
Oxycodone with naloxone
Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg
Oral
Targin 5/2.5mg
MF
MP NP
C1062

28
0

Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg
Oral
Targin 10/5mg
MF
MP NP
C1062

28
0

Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg
Oral
Targin 20/10mg
MF
MP NP
C1062

28
0

Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg
Oral
Targin 40/20mg
MF
MP NP
C1062

28
0

[63]         Schedule 1, entry for Paclitaxel
substitute:

Paclitaxel
Solution concentrate for I.V. infusion 30 mg in 5 mL
Injection
Anzatax
HH
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Actavis
TA
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Ebewe
SZ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Kabi
PK
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Plaxel
WQ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Taxol
BQ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 100 mg in 16.7 mL
Injection
Anzatax
HH
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Actavis
TA
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Ebewe
SZ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Kabi
PK
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Plaxel
WQ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Taxol
BQ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 150 mg in 25 mL
Injection
Anzatax
HH
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Actavis
TA
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Ebewe
SZ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Plaxel
WQ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Solution concentrate for I.V. infusion 300 mg in 50 mL
Injection
Anzatax
HH
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Actavis
TA
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Ebewe
SZ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Paclitaxel Kabi
PK
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Plaxel
WQ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

Taxol
BQ
MP
See Note 1
C3186 C3890 C3893 C3902 C3917 C3918

See Note 3
See Note 3
D

[64]         Schedule 1, entry for Paclitaxel, nanoparticle albumin-bound
substitute:
Paclitaxel, nanoparticle albumin-bound
Powder for I.V. injection containing 100 mg paclitaxel
Injection
Abraxane
TS
MP
See Note 1
C3897

See Note 3
See Note 3
D
[65]         Schedule 1, after entry for Paliperidone in the form Tablet 9 mg (prolonged release)
insert in the columns in the order indicated:

I.M. injection (modified release) 25 mg (as palmitate) in pre-filled syringe
Injection
Invega Sustenna
JC
MP NP
C1589

1
5

I.M. injection (modified release) 50 mg (as palmitate) in pre-filled syringe
Injection
Invega Sustenna
JC
MP NP
C1589

1
5

I.M. injection (modified release) 75 mg (as palmitate) in pre-filled syringe
Injection
Invega Sustenna
JC
MP NP
C1589

1
5

I.M. injection (modified release) 100 mg (as palmitate) in pre-filled syringe
Injection
Invega Sustenna
JC
MP NP
C1589

1
5

I.M. injection (modified release) 150 mg (as palmitate) in pre-filled syringe
Injection
Invega Sustenna
JC
MP NP
C1589

1
5

[66]         Schedule 1, entry for Pemetrexed
substitute:
Pemetrexed
Powder for I.V. infusion 100 mg (as disodium heptahydrate)
Injection
Alimta
LY
MP
See Note 1
C2957 C2958 C3885 C3886

See Note 3
See Note 3
D

Powder for I.V. infusion 500 mg (as disodium heptahydrate)
Injection
Alimta
LY
MP
See Note 1
C2957 C2958 C3885 C3886

See Note 3
See Note 3
D

[67]         Schedule 1, entry for Perindopril in each of the forms: Tablet containing perindopril erbumine 2 mg; Tablet containing perindopril erbumine 4 mg; and Tablet containing perindopril erbumine 8 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Perindopril generichealth
GQ
MP NP

30
5

[68]         Schedule 1, after entry for Pramipexole in the form Tablet (extended release) containing pramipexole hydrochloride 1.5 mg
insert in the columns in the order indicated:

Tablet (extended release) containing pramipexole hydrochloride 2.25 mg
Oral
Sifrol ER
BY
MP NP
C3216

30
5

[69]         Schedule 1, after entry for Pramipexole in the form Tablet (extended release) containing pramipexole hydrochloride 3 mg
insert in the columns in the order indicated:

Tablet (extended release) containing pramipexole hydrochloride 3.75 mg
Oral
Sifrol ER
BY
MP NP
C3216

30
5

[70]         Schedule 1, entry for Raltitrexed
substitute:
Raltitrexed
Powder for I.V. infusion 2 mg in single use vial
Injection
Tomudex
HH
MP
See Note 1
C3185

See Note 3
See Note 3
D
[71]         Schedule 1, entry for Ribavirin and PegInterferon Alfa-2b in each of the forms: Pack containing 112 capsules ribavirin 200 mg and
4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent; Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent; and Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent
omit from the column headed “Circumstances”:
C3055 C3413
insert in numerical order:
C3948 C3949
[72]         Schedule 1, entry for Rituximab
substitute:
Rituximab
Solution for I.V. infusion 100 mg in 10 mL
Injection
Mabthera
RO
MP
See Note 1
C1744 C1745 C2068 C2386 C3908 C3909 C3912 C3915 C3931 C3932
See Note 3
See Note 3
See Note 3
D

Solution for I.V. infusion 500 mg in 50 mL
Injection
Mabthera
RO
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

MP
See Note 1
C1744 C1745 C2068 C2386 C3908 C3909 C3912 C3915 C3931 C3932
See Note 3
See Note 3
See Note 3
D

[73]         Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Max Quantity 5; Number of Repeats 0]
(a)        omit from the column headed “Responsible Person”:                 SZ          substitute:             HX
(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Roxithromycin Sandoz
SZ
PDP

5
0

[74]         Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Max Quantity 5; Number of Repeats 1]
(a)        omit from the column headed “Responsible Person”:                 SZ          substitute:             HX
(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Roxithromycin Sandoz
SZ
MP NP

5
1

[75]         Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)
(a)        omit from the column headed “Responsible Person”:                 SZ          substitute:             HX
(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Sertraline Sandoz
SZ
MP NP
C1211

30
5

[76]         Schedule 1, entry for Somatropin in each of the forms: Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative); Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative); and Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Norditropin FlexPro
NO
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
[77]         Schedule 1, entry for Temozolomide
substitute:

Temozolomide
Capsule 140 mg
Oral
Astromide
WQ
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Temizole 140
QA
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Temodal
MK
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Astromide
WQ
MP
C1736 C1737 C2100 C2101
P2100
15
2

Temizole 140
QA
MP
C1736 C1737 C2100 C2101
P2100
15
2

Temodal
MK
MP
C1736 C1737 C2100 C2101
P2100
15
2

Capsule 5 mg
Oral
Astromide
WQ
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Temizole 5
QA
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Temodal
MK
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Astromide
WQ
MP
C1736 C1737 C2100 C2101
P2100
15
2

Temizole 5
QA
MP
C1736 C1737 C2100 C2101
P2100
15
2

Temodal
MK
MP
C1736 C1737 C2100 C2101
P2100
15
2

Capsule 20 mg
Oral
Astromide
WQ
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Temizole 20
QA
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Temodal
MK
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Astromide
WQ
MP
C1736 C1737 C2100 C2101
P2100
15
2

Temizole 20
QA
MP
C1736 C1737 C2100 C2101
P2100
15
2

Temodal
MK
MP
C1736 C1737 C2100 C2101
P2100
15
2

Capsule 100 mg
Oral
Astromide
WQ
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Temizole 100
QA
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Temodal
MK
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5

Astromide
WQ
MP
C1736 C1737 C2100 C2101
P2100
15
2

Temizole 100
QA
MP
C1736 C1737 C2100 C2101
P2100
15
2

Temodal
MK
MP
C1736 C1737 C2100 C2101
P2100
15
2

Capsule 250 mg
Oral
Astromide
WQ
MP
C1736 C1737 C2101

5
5

Temizole 250
QA
MP
C1736 C1737 C2101

5
5

Temodal
MK
MP
C1736 C1737 C2101

5
5

[78]         Schedule 1, omit entry for Thiotepa
[79]         Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Topiramate generichealth
GQ
MP NP
C2797 C2799

60
5

[80]         Schedule 1, entry for Topiramate in each of the forms: Tablet 100 mg; and Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Topiramate generichealth
GQ
MP NP
C2797

60
5

[81]         Schedule 1, entry for Topotecan
substitute:
Topotecan
Powder for I.V. infusion 4 mg (as hydrochloride)
Injection
Hycamtin
GK
MP
See Note 1
C3186

See Note 3
See Note 3
D
[82]         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”:

Valaciclovir generichealth
GQ
MP NP
C3622 C3623 C3624 C3631
P3623 P3624
30
5

[83]         Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [MaxQuantity 42; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Valaciclovir generichealth
GQ
MP NP
C3622 C3623 C3624 C3631
P3622 P3631
42
0

[84]         Schedule 1, entry for Vinblastine
substitute:
Vinblastine
Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL
Injection
Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

[85]         Schedule 1, entry for Vincristine
substitute:
Vincristine
I.V. injection containing vincristine sulfate 1 mg in 1 mL
Injection
Hospira Pty Limited
HH
MP
See Note 1

See Note 3
See Note 3
D

Pfizer Australia Pty Ltd
PF
MP
See Note 1

See Note 3
See Note 3
D

[86]         Schedule 1, entry for Vinorelbine
substitute:
Vinorelbine
Capsule 20 mg (as tartrate)
Oral
Navelbine
FB
MP
C1194

20
2

Capsule 30 mg (as tartrate)
Oral
Navelbine
FB
MP
C1194

16
2

Solution for I.V. infusion 10 mg (as tartrate) in 1 mL
Injection
Hospira Pty Limited
HH
MP
See Note 1
C3890 C3907

See Note 3
See Note 3
PB

Navelbine
FB
MP
See Note 1
C3890 C3907

See Note 3
See Note 3
PB

Vinorelbine Ebewe
SZ
MP
See Note 1
C3890 C3907

See Note 3
See Note 3
PB

Solution for I.V. infusion 50 mg (as tartrate) in 5 mL
Injection
Hospira Pty Limited
HH
MP
See Note 1
C3890 C3907

See Note 3
See Note 3
PB

Navelbine
FB
MP
See Note 1
C3890 C3907

See Note 3
See Note 3
PB

Vinorelbine Ebewe
SZ
MP
See Note 1
C3890 C3907

See Note 3
See Note 3
PB

Vinorelbine Kabi
PK
MP
See Note 1
C3890 C3907

See Note 3
See Note 3
PB

[87]         Schedule 1, entry for Zoledronic Acid in the form Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL
omit from the column headed “Circumstances”:
C3287 C3288
C3289 C3290
substitute:
C3290 C3945
C3946 C3947
[88]         Schedule 3
omit:
CO
Chemists’ Own Pty Ltd
45 000 585 197
[89]         Schedule 4, Part 1, entry for Alendronic Acid
(a)        omit:

C2645

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 2645
(b)        insert after existing text in the columns in the order indicated:

C3933

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -2.5 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 3933

[90]         Schedule 4, Part 1, entry for Alendronic acid with colecalciferol
(a)        omit:

C2645

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 2645
(b)        insert after existing text in the columns in the order indicated:

C3933

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -2.5 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 3933
[91]         Schedule 4, Part 1, entry for Alendronic acid with colecalciferol and calcium
(a)        omit:

C2645

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 2645
(b)        insert after existing text in the columns in the order indicated:

C3933

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -2.5 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 3933
[92]         Schedule 4, Part 1, entry for Arsenic
substitute:

C3150

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Induction and consolidation treatment of relapsed acute promyelocytic leukaemia (characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript) in a patient who is arsenic naive at induction
Compliance with Authority Required Procedures

C3891

Where the patient is receiving treatment at/from a Public Hospital
Induction and consolidation treatment of relapsed acute promyelocytic leukaemia (characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript) in a patient who is arsenic naive at induction
Compliance with Authority Required procedures - Streamlined Authority Code 3891

[93]         Schedule 4, Part 1, after entry for Artemether with lumefantrine
insert:
Asenapine
C1589

Schizophrenia
Compliance with Authority Required procedures - Streamlined Authority Code 1589

C3935

Treatment, for up to 6 months, of an episode of acute mania or mixed episodes associated with bipolar I disorder
Compliance with Authority Required procedures - Streamlined Authority Code 3935

C3936

Maintenance treatment, as monotherapy, of bipolar I disorder
Compliance with Authority Required procedures - Streamlined Authority Code 3936

[94]         Schedule 4, Part 1, entry for Bevacizumab
substitute:

C3430

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Initial PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks
Compliance with Authority Required Procedures

C3431

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Continuing PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with metastatic colorectal cancer who has who has previously been issued with an authority prescription for bevacizumab and who does not have progressive disease and who remains on first-line chemotherapy, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks
Compliance with Authority Required Procedures

C3894

Where the patient is receiving treatment at/from a Public Hospital
Initial PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks, and where the patient's WHO performace status and body weight is recorded in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 3894

C3896

Where the patient is receiving treatment at/from a Public Hospital
Continuing PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with metastatic colorectal cancer who has previously received PBS-subsidised treatment with bevacizumab and who does not have progressive disease and who remains on first-line chemotherapy, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks, and where the patient's body weight is documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 3896

[95]         Schedule 4, Part 1, entry for Budesonide with Eformoterol
insert after existing text in the columns in the order indicated:

C2680

Symptomatic treatment of chronic obstructive pulmonary disease (COPD), where the forced expiratory volume in 1 second (FEV1) is less than 50% predicted normal and there is a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy

[96]         Schedule 4, Part 1, entry for Capecitabine
(a)        omit:

C2267

Adjuvant treatment of stage III (Dukes C) colon cancer, following complete resection of the primary tumour
Compliance with Authority Required procedures
(b)        insert after existing text in the columns in the order indicated:

C3942

Adjuvant treatment of stage III (Dukes C) colon cancer, following complete resection of the primary tumour either as:
(a) monotherapy; or
(b) in combination with oxaliplatin
Compliance with Authority Required procedures
[97]         Schedule 4, Part 1, entry for Cetuximab
substitute:

C2713

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy
Compliance with Authority Required procedures

C2714

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease
Compliance with Authority Required procedures

C2715

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration-approved Product Information
Compliance with Authority Required procedures

C3843

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated
Compliance with Authority Required procedures

C3844

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated
Compliance with Authority Required procedures

C3903

Where the patient is receiving treatment at/from a Public Hospital
Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy
Compliance with Authority Required procedures - Streamlined Authority Code 3903

C3904

Where the patient is receiving treatment at/from a Public Hospital
Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease
Compliance with Authority Required procedures - Streamlined Authority Code 3904

C3919

Where the patient is receiving treatment at/from a Public Hospital
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration-approved Product Information
Compliance with Authority Required procedures - Streamlined Authority Code 3919

C3920

Where the patient is receiving treatment at/from a Public Hospital
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated
Compliance with Authority Required procedures - Streamlined Authority Code 3920

C3921

Where the patient is receiving treatment at/from a Public Hospital
Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated
Compliance with Authority Required procedures - Streamlined Authority Code 3921

[98]         Schedule 4, Part 1, entry for Dalteparin
insert after existing text in the columns in the order indicated:

C3688
P3688
Management of symptomatic venous thromboembolism in a patient with a solid tumour(s)

[99]         Schedule 4, Part 1, entry for Darunavir
insert after existing text in the columns in the order indicated:

C3940

Where the patient is receiving treatment at/from a Private Hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Required procedures

C3941

Where the patient is receiving treatment at/from a Public Hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3941

[100]       Schedule 4, Part 1, entry for Denosumab
substitute:
Denosumab
C1035

Bone metastases from breast cancer
Compliance with Authority Required procedures

C3579

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures

C3580

Treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal osteoporosis in a woman with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures

C3881

Bone metastases from hormone-resistant prostate cancer.
Compliance with Authority Required procedures

[101]       Schedule 4, Part 1, entry for Docetaxel
substitute:

C3186

Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
Compliance with Authority Required procedures - Streamlined Authority Code 3186

C3884

Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles
Compliance with Authority Required procedures - Streamlined Authority Code 3884

C3888

Neoadjuvant treatment of a patient with a World Health Organisation performance status of 1 or less, with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx, in combination with cisplatin and fluorouracil
Compliance with Authority Required procedures - Streamlined Authority Code 3888

C3890

Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures - Streamlined Authority Code 3890

C3892

Adjuvant treatment of operable breast cancer in combination with cyclophosphamide
Compliance with Authority Required procedures - Streamlined Authority Code 3892

C3893

Advanced breast cancer after failure of prior therapy
Compliance with Authority Required procedures - Streamlined Authority Code 3893

C3916

Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide
Compliance with Authority Required procedures - Streamlined Authority Code 3916

C3918

Treatment of HER2 positive early breast cancer in combination with trastuzumab
Compliance with Authority Required procedures - Streamlined Authority Code 3918

[102]       Schedule 4, Part 1, entry for Doxorubicin ─ Pegylated Liposomal
(a)        insert as first line in the column headed “Circumstances and Purposes” in respect of each of the Circumstances Codes: C1568; C1795; and C1796:
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
(b)        insert after existing text in the columns in the order indicated:

C3905

Where the patient is receiving treatment at/from a Public Hospital
Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen
Compliance with Authority Required procedures - Streamlined Authority Code 3905

C3910

Where the patient is receiving treatment at/from a Public Hospital
Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane
Compliance with Authority Required procedures - Streamlined Authority Code 3910

C3911

Where the patient is receiving treatment at/from a Public Hospital
Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated
Compliance with Authority Required procedures - Streamlined Authority Code 3911

[103]       Schedule 4, Part 1, entry for Fludarabine
insert after existing text in the columns in the order indicated:

C3887

B-cell chronic lymphocytic leukaemia in combination with cyclophosphamide where the patient has advanced disease (Binet Stage B or C) or evidence of progressive Stage A disease, and where:
(1) Stage A progressive disease is defined by at least 1 of the following:
— persistent rise in lymphocyte count with doubling time less than 12 months;
— a downward trend in haemoglobin or platelets, or both;
— more than 50% increase in the size of liver, spleen, or lymph nodes, or appearance of these signs if not previously present;
— constitutional symptoms attributable to disease; and
(2) the diagnosis of chronic lymphocytic leukaemia has been established based on:
(a) a lymphocytosis, with more than 5,000 million lymphocytes per L in the peripheral blood; and
(b) a clonal population of B-cells (CD5/CD19) documented by flow cytometry
Compliance with Authority Required procedures - Streamlined Authority Code 3887
[104]       Schedule 4, Part 1, entry for Gemcitabine
substitute:

C1193

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Locally advanced or metastatic adenocarcinoma of the pancreas
Compliance with Authority Required procedures

C1194

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures

C1740

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Locally advanced or metastatic bladder cancer, in combination with cisplatin
Compliance with Authority Required procedures

C2069

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Advanced breast cancer in combination with paclitaxel after failure of prior therapy which includes an anthracycline
Compliance with Authority Required procedures

C2141

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Advanced epithelial ovarian cancer, in combination with carboplatin, in patients who relapse more than 6 months after platinum-based therapy
Compliance with Authority Required procedures

C3889

Where the patient is receiving treatment at/from a Public Hospital
Locally advanced or metastatic adenocarcinoma of the pancreas
Compliance with Authority Required procedures - Streamlined Authority Code 3889

C3890

Where the patient is receiving treatment at/from a Public Hospital
Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures - Streamlined Authority Code 3890

C3906

Where the patient is receiving treatment at/from a Public Hospital
Locally advanced or metastatic bladder cancer, in combination with cisplatin
Compliance with Authority Required procedures - Streamlined Authority Code 3906

C3913

Where the patient is receiving treatment at/from a Public Hospital
Advanced breast cancer in combination with paclitaxel after failure of prior therapy which includes an anthracycline
Compliance with Authority Required procedures - Streamlined Authority Code 3913

C3914

Where the patient is receiving treatment at/from a Public Hospital
Advanced epithelial ovarian cancer, in combination with carboplatin, in patients who relapse more than 6 months after platinum-based therapy
Compliance with Authority Required procedures - Streamlined Authority Code 3914

[105]       Schedule 4, Part 1, after entry for Imiquimod
insert:
Indacaterol
C3883

Chronic obstructive pulmonary disease

[106]       Schedule 4, Part 1, entry for Interferon Alfa-2a
(a)        insert as first line in the column headed “Circumstances and Purposes” in respect of each of the Circumstances Codes: C1149; C1196; and C1234:
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
(b)           insert in numerical order for the column headed “Circumstances Code”:

C3180

Where the patient is receiving treatment at/from a Public Hospital
Hairy cell leukaemia
Compliance with Authority Required procedures - Streamlined Authority Code 3180
(c)           insert after existing text in the columns in the order indicated:

C3895

Where the patient is receiving treatment at/from a Public Hospital
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Compliance with Authority Required procedures - Streamlined Authority Code 3895

C3899

Where the patient is receiving treatment at/from a Public Hospital
Myeloproliferative disease with excessive thrombocytosis
Compliance with Authority Required procedures - Streamlined Authority Code 3899

[107]       Schedule 4, Part 1, entry for Interferon Alfa-2b
(a)        insert as first line in the column headed “Circumstances and Purposes” in respect of each of the Circumstances Codes: C1149; C1196; and C1206:
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
(b)           insert in numerical order for the column headed “Circumstances Code”:

C3180

Where the patient is receiving treatment at/from a Public Hospital
Hairy cell leukaemia
Compliance with Authority Required procedures - Streamlined Authority Code 3180
(c)           insert after existing text in the columns in the order indicated:

C3895

Where the patient is receiving treatment at/from a Public Hospital
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Compliance with Authority Required procedures - Streamlined Authority Code 3895

C3898

Where the patient is receiving treatment at/from a Public Hospital
Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy
Compliance with Authority Required procedures - Streamlined Authority Code 3898

[108]       Schedule 4, Part 1, after entry for Macrogol 3350
insert:
Magnesium
C3937

Hypomagnesaemia in an Aboriginal or a Torres Strait Islander person
Compliance with Authority Required procedures

C3938

Chronic renal disease in an Aboriginal or a Torres Strait Islander person
Compliance with Authority Required procedures

[109]       Schedule 4, Part 1, entry for Oxaliplatin
substitute:
Oxaliplatin
C3900

Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with capecitabine
Compliance with Authority Required procedures - Streamlined Authority Code 3900

C3901

Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil and folinic acid
Compliance with Authority Required procedures - Streamlined Authority Code 3901

C3930

Adjuvant treatment of stage III (Dukes C) colon cancer following complete resection of the primary tumour used in combination with capecitabine
Compliance with Authority Required procedures - Streamlined Authority Code 3930

C3939

Adjuvant treatment of stage III (Dukes C) colon cancer following complete resection of the primary tumour used in combination with 5-fluorouracil and folinic acid
Compliance with Authority Required procedures - Streamlined Authority Code 3939

[110]       Schedule 4, Part 1, after entry for Oxycodone
insert:
Oxycodone with naloxone
C1062

Chronic severe disabling pain not responding to non-narcotic analgesics.

[111]       Schedule 4, Part 1, entry for Paclitaxel
substitute:
Paclitaxel
C3186

Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
Compliance with Authority Required procedures - Streamlined Authority Code 3186

C3890

Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures - Streamlined Authority Code 3890

C3893

Advanced breast cancer after failure of prior therapy
Compliance with Authority Required procedures - Streamlined Authority Code 3893

C3902

Primary treatment of ovarian cancer in combination with a platinum compound
Compliance with Authority Required procedures - Streamlined Authority Code 3902

C3917

Adjuvant treatment of node-positive breast cancer administered sequentially to an anthracycline and cyclophosphamide
Compliance with Authority Required procedures - Streamlined Authority Code 3917

C3918

Treatment of HER2 positive early breast cancer in combination with trastuzumab
Compliance with Authority Required procedures - Streamlined Authority Code 3918

[112]       Schedule 4, Part 1, entry for Paclitaxel, nanoparticle albumin-bound
substitute:
Paclitaxel, nanoparticle albumin-bound
C3897

Metastatic breast cancer after failure of prior therapy
Compliance with Authority Required procedures - Streamlined Authority Code 3897
[113]       Schedule 4, Part 1, entry for Pemetrexed
substitute:

C2957

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is included in the authority application
Compliance with Authority Required procedures

C2958

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Mesothelioma, in combination with cisplatin, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is included in the authority application
Compliance with Authority Required procedures

C3885

Where the patient is receiving treatment at/from a Public Hospital
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 3885

C3886

Where the patient is receiving treatment at/from a Public Hospital
Mesothelioma, in combination with cisplatin, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 3886

[114]       Schedule 4, Part 1, entry for Ribavirin and Peginterferon Alfa-2b
insert after existing text in the columns in the order indicated:

C3948

Where the patient is receiving treatment at/from a Private Hospital
Patients naive to interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients weighing at least 27 kg who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant.
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks.
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12.
Compliance with Written or Telephone Authority Required procedures

C3949

Where the patient is receiving treatment at/from a public hospital
Patients naive to interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients weighing at least 27 kg who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant.
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks.
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3949

[115]       Schedule 4, Part 1, entry for Rituximab
substitute:

C1744

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma
Compliance with Authority Required procedures

C1745

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Compliance with Authority Required procedures

C2068

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Compliance with Authority Required procedures

C2386

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma in combination with chemotherapy
Compliance with Authority Required procedures

C3908

Where the patient is receiving treatment at/from a Public Hospital
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma
Compliance with Authority Required procedures - Streamlined Authority Code 3908

C3909

Where the patient is receiving treatment at/from a Public Hospital
Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Compliance with Authority Required procedures - Streamlined Authority Code 3909

C3912

Where the patient is receiving treatment at/from a Public Hospital
Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Compliance with Authority Required procedures - Streamlined Authority Code 3912

C3915

Where the patient is receiving treatment at/from a Public Hospital
Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma in combination with chemotherapy
Compliance with Authority Required procedures - Streamlined Authority Code 3915

C3931

Where the patient is receiving treatment in the community setting or at/from a Private Hospital
CD20 positive, chronic lymphocytic leukaemia, in combination with fludarabine and cyclophosphamide
Compliance with Authority Required procedures

C3932

Where the patient is receiving treatment at/from a Public Hospital
CD20 positive, chronic lymphocytic leukaemia, in combination with fludarabine and cyclophosphamide
Compliance with Authority Required procedures - Streamlined Authority Code 3932

[116]       Schedule 4, Part 1, entry for Vinorelbine
(a)        omit:

C1741

Advanced breast cancer after failure of prior therapy which includes an anthracycline
Compliance with Authority Required procedures
(b)        insert after existing text in the columns in the order indicated:

C3890

Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures - Streamlined Authority Code 3890

C3907

Advanced breast cancer after failure of prior therapy which includes an anthracycline
Compliance with Authority Required procedures - Streamlined Authority Code 3907

[117]       Schedule 4, Part 1, entry for Zoledronic acid
(a)        omit:

C3287

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated, and where PBS-subsidised treatment is limited to 3 doses per patient in their lifetime, administered as 1 dose each year for 3 years
Compliance with Authority Required procedures

C3288

Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in a patient with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body, and where PBS-subsidised treatment is limited to 3 doses per patient in their lifetime, administered as 1 dose each year for 3 years
Compliance with Authority Required procedures

C3289

Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated, and where PBS-subsidised treatment is limited to 3 doses per patient in their lifetime, administered as 1 dose each year for 3 years
Compliance with Authority Required procedures

(b)        insert after existing text in the columns in the order indicated:

C3945

Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated, and where PBS-subsidised treatment is limited to 1 dose per patient each year
Compliance with Authority Required procedures - Streamlined Authority Code 3945

C3946

Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in a patient with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body, and where PBS-subsidised treatment is limited to 1 dose per patient per year
Compliance with Authority Required procedures - Streamlined Authority Code 3946

C3947

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated, and where PBS-subsidised treatment is limited to 1 dose per patient each year
Compliance with Authority Required procedures - Streamlined Authority Code 3947

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.