National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 12) (No. PB 83 of 2011) (Cth)
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
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.
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.
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
Schedule 1, entry for Alendronic acid with colecalciferol
omit from the column headed “Circumstances” (all instances):
C2645
insert in numerical order:
C3933
Schedule 1, entry for Alendronic acid with colecalciferol and calcium
omit from the column headed “Circumstances” (twice occurring):
C2645
insert in numerical order:
C3933
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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
Schedule 1, entry for Capecitabine
omit from the column headed “Circumstances” (twice occurring):
C2267
insert in numerical order:
C3942
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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
Schedule 1, entry for Lacosamide
omit:
| Oral solution 15 mg per mL, 200 mL | Oral | Vimpat | UC | MP NP | C3303 C3304 | 2 | 5 |
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 |
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 |
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 |
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
omit:
| Glucohexal | HX | MP NP | 100 | 5 |
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit:
| Glucohexal | HX | MP NP | 60 | 5 |
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
omit:
| Glucohexal | HX | MP NP | 90 | 5 |
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 |
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 |
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 |
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 |
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 |
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 |
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
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 |
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
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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
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 |
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 |
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 |
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 |
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 |
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 |
Schedule 1, omit entry for Thiotepa
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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
Schedule 3
omit:
| CO | Chemists’ Own Pty Ltd | 45 000 585 197 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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) |
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. | 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. | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3941 |
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 |
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 |
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 |
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 |
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 |
Schedule 4, Part 1, after entry for Imiquimod
insert:
| Indacaterol | C3883 | Chronic obstructive pulmonary disease |
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 |
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 |
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 |
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 |
Schedule 4, Part 1, after entry for Oxycodone
insert:
| Oxycodone with naloxone | C1062 | Chronic severe disabling pain not responding to non-narcotic analgesics. |
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 |
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 |
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 |
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) | 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) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3949 |
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 |
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 |
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.
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