National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 7) (No. PB 60 of 2012) (Cth)

Case

PB 60 of 2012

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No. 7)1

National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 9 August 2012

FELICITY McNEILL

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 2012 (No. 7).

(2)        This Instrument may also be cited as PB 60 of 2012.

2          Commencement

Schedule 1 to this Instrument commences on 1 August 2012, immediately following commencement of PB 44 of 2012.

Schedule 2 to this Instrument commences on 1 September 2012.

3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)

Schedules 1 and 2 amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).

Schedule 1     Amendment

  1. Schedule 4, Part 1, after entry for Ranibizumab

insert:

Rasagiline C4053 Parkinson disease Compliance with Authority Required procedures – Streamlined Authority Code 4053

Schedule 2     Amendments

  1. Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate) [Max Quantity 20; Number of Repeats 0]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Amoxycillin-PS FZ PDP 20 0

  1. Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate) [Max Quantity 20; Number of Repeats 1]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Amoxycillin-PS FZ MP NP MW 20 1

  1. Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate) [Max Quantity 20; Number of Repeats 0]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Amoxycillin-PS FZ PDP 20 0

  1. Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate) [Max Quantity 20; Number of Repeats 1]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Amoxycillin-PS FZ MP NP MW 20 1

  1. Schedule 1, entry for Azathioprine in the form Tablet 50 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Azathioprine-PS FZ MP NP 100 5

  1. Schedule 1, entry for Calcipotriol

omit:

Scalp solution 50 micrograms (as monohydrate) per mL, 30 mL Application Daivonex LO MP NP C2963 1 1

  1. Schedule 1, entry for Cefepime

omit from the column headed “Form” (twice occurring):

(with any determined brand of sodium chloride injection as the required solvent)

  1. Schedule 1, entry for Ceftriaxone

omit:

Powder for injection 500 mg (as sodium) Injection Ceftriaxone ICP PP MP NP C1143 C1169 C1846 C1847 P1143 1 0
MP NP C1143 C1169 C1846 C1847 P1169 P1846 P1847 5 0

substitute:

Powder for injection 500 mg (as sodium) Injection Ceftriaxone-AFT AE MP NP C1143 C1169 C1846 C1847 P1143 1 0
Ceftriaxone ICP PP MP NP C1143 C1169 C1846 C1847 P1143 1 0
Ceftriaxone-AFT AE MP NP C1143 C1169 C1846 C1847 P1169 P1846 P1847 5 0
Ceftriaxone ICP PP MP NP C1143 C1169 C1846 C1847 P1169 P1846 P1847 5 0

  1. Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)

omit:

A-Citalopram TA MP NP C1211 28 5

  1. Schedule 1, entry for Clarithromycin in the form Tablet 250 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Clarithromycin-PS FZ MP NP 14 1

  1. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

omit:

Pharmacor Clopidogrel 75 CR MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5

  1. Schedule 1, entry for Cyclosporin in the form Capsule 25 mg [Max Quantity 60; Number of Repeats 3]

(a) omit:

Cicloral SZ MP C2049 C2050 C2051 C2052 C2053 60 3

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Cyclosporin Sandoz SZ MP C2049 C2050 C2051 C2052 C2053 60 3

  1. Schedule 1, entry for Cyclosporin in the form Capsule 25 mg [Max Quantity 120; Number of Repeats 5]

(a) omit:

Cicloral SZ MP
See Note 1 		C1654 C1655 C1656 C1657 C1658 C3328 C3329 C3330 C3331 C3332 120 5 C

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Cyclosporin Sandoz SZ MP
See Note 1 		C1654 C1655 C1656 C1657 C1658 C3328 C3329 C3330 C3331 C3332 120 5 C

  1. Schedule 1, entry for Cyclosporin in the form Capsule 50 mg [Max Quantity 60; Number of Repeats 3]

(a) omit:

Cicloral SZ MP C2049 C2050 C2051 C2052 C2053 60 3

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Cyclosporin Sandoz SZ MP C2049 C2050 C2051 C2052 C2053 60 3

  1. Schedule 1, entry for Cyclosporin in the form Capsule 50 mg [Max Quantity 120; Number of Repeats 5]

(a) omit:

Cicloral SZ MP
See Note 1 		C1654 C1655 C1656 C1657 C1658 C3328 C3329 C3330 C3331 C3332 120 5 C

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Cyclosporin Sandoz SZ MP
See Note 1 		C1654 C1655 C1656 C1657 C1658 C3328 C3329 C3330 C3331 C3332 120 5 C

  1. Schedule 1, entry for Cyclosporin in the form Capsule 100 mg [Max Quantity 60; Number of Repeats 3]

(a) omit:

Cicloral SZ MP C2049 C2050 C2051 C2052 C2053 60 3

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Cyclosporin Sandoz SZ MP C2049 C2050 C2051 C2052 C2053 60 3

  1. Schedule 1, entry for Cyclosporin in the form Capsule 100 mg [Max Quantity 120; Number of Repeats 5]

(a) omit:

Cicloral SZ MP
See Note 1 		C1654 C1655 C1656 C1657 C1658 C3328 C3329 C3330 C3331 C3332 120 5 C

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Cyclosporin Sandoz SZ MP
See Note 1 		C1654 C1655 C1656 C1657 C1658 C3328 C3329 C3330 C3331 C3332 120 5 C

  1. Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Max Quantity 20; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Cyprocur 50 QA MP C1014 C1230 C1404 P1230 20 5

  1. Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Max Quantity 100; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Cyprocur 50 QA MP C1014 C1230 C1404 P1014 P1404 100 5

  1. Schedule 1, entry for Dicloxacillin in each of the forms: Capsule 250 mg (as sodium); and Capsule 500 mg (as sodium)

omit:

Dicloxsig QA MP NP MW PDP C1345 24 0

  1. Schedule 1, omit entry for Dihydroergotamine

  1. Schedule 1, entry for Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg

omit:

Diltahexal CD HX MP NP 30 5

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [Docetaxel Sandoz]

insert in numerical order in the column headed “Circumstances”:

C3892

  1. Schedule 1, entry for Docetaxel

omit:

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 C3186 C3888 C3890 C3892 C3916 C3955 C3956 C7002 See Note 3 See Note 3 See Note 3 D

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL [Docetaxel Sandoz]

insert in numerical order in the column headed “Circumstances”:

C3892

  1. Schedule 1, omit entry for Etidronic Acid

  1. Schedule 1, omit entry for Etidronic Acid and Calcium

  1. Schedule 1, entry for Famotidine in the form Tablet 20 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Famotidine-PS FZ MP NP 60 5

  1. Schedule 1, entry for Famotidine in the form Tablet 40 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Famotidine-PS FZ MP NP 30 5

  1. Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Fluconazole Alphapharm AF MP NP C3613 C3614 C3615 C3616 C3617 C3618 7 0

  1. Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 400 mg in 200 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Fluconazole Alphapharm AF MP NP C3613 C3614 C3615 C3616 C3617 C3618 1 0

  1. Schedule 1, entry for Glucose Indicator―Blood

omit:

Test strips, 25 (On-Call Plus) For external use On-Call Plus PZ MP NP 4 5
MP P3035 4 11

  1. Schedule 1, entry for Isosorbide Mononitrate in the form Tablet 60 mg (sustained release)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Isosorbide-PS FZ MP NP 30 5

  1. Schedule 1, entry for Lamivudine in the form Tablet 100 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Zetlam AF MP
See Note 1 		C3959 C3960 C3961 C3962 56 5 D

  1. Schedule 1, entry for Lamivudine in the form Tablet 150 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Alphapharm Lamivudine AF MP
See Note 1 		C3586 C3587 C3588 C3589 120 5 D

  1. Schedule 1, entry for Lamivudine in the form Tablet 300 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Alphapharm Lamivudine AF MP
See Note 1 		C3586 C3587 C3588 C3589 60 5 D

  1. Schedule 1, entry for Methoxyflurane

omit from the column headed “Responsible Person”: NQ          substitute: DV

  1. Schedule 1, entry for Methylprednisolone in the form Powder for injection 1 g (as sodium succinate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Methylprednisolone Alphapharm AF MP NP 1 0

  1. Schedule 1, entry for Omeprazole in the form Tablet 20 mg

(a) omit:

Omeprazole Ranbaxy RA MP NP C1177 C1337 C1476 C1533 P1177 30 1

(b) omit:

Omeprazole Ranbaxy RA MP NP C1177 C1337 C1476 C1533 P1337 P1476 P1533 30 5

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30;
    Number of Repeats 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

STADA Pantoprazole TD MP NP C1177 C1337 C1476 C1533 P1177 30 2

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30;
    Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

STADA Pantoprazole TD MP NP C1177 C1337 C1476 C1533 P1337 P1476 P1533 30 5

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg

(a) omit:

Chem mart Paracetamol XS PDP 100 0

(b) omit:

Pharmacy Choice Paracetamol YM PDP 100 0
Terry White Chemists Paracetamol YS PDP 100 0

(c) omit:

Chem mart Paracetamol XS MP NP 100 1

(d) omit:

Pharmacy Choice Paracetamol YM MP NP 100 1
Terry White Chemists Paracetamol YS MP NP 100 1

(e) omit:

Chem mart Paracetamol XS PDP P2046 300 0

(f) omit:

Pharmacy Choice Paracetamol YM PDP P2046 300 0
Terry White Chemists Paracetamol YS PDP P2046 300 0

(g) omit:

Chem mart Paracetamol XS MP NP P2046 300 4

(h) omit:

Pharmacy Choice Paracetamol YM MP NP P2046 300 4
Terry White Chemists Paracetamol YS MP NP P2046 300 4

  1. Schedule 1, entry for Pioglitazone in the form Tablet 15 mg (as hydrochloride)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Prioten 15 DO MP NP C3540 C3541 C3542 28 5

  1. Schedule 1, entry for Pioglitazone in the form Tablet 30 mg (as hydrochloride)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Prioten 30 DO MP NP C3540 C3541 C3542 28 5

  1. Schedule 1, entry for Pioglitazone in the form Tablet 45 mg (as hydrochloride)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Prioten 45 DO MP NP C3540 C3541 C3542 28 5

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 2]

(a) omit:

Risperidone Actavis 0.5 TA MP NP C1589 C2061 C3083 P2061 P3083 60 2

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Risperidone GH GQ MP NP C1589 C2061 C3083 P2061 P3083 60 2

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 5]

(a) omit:

Risperidone Actavis 0.5 TA MP NP C1589 C2061 C3083 P1589 60 5

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Risperidone GH GQ MP NP C1589 C2061 C3083 P1589 60 5

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 2]

omit:

Risperidone Actavis 1 TA MP NP C1589 C2061 C2272 C3083 P2061 P3083 60 2

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 5]

omit:

Risperidone Actavis 1 TA MP NP C1589 C2061 C2272 C3083 P1589 P2272 60 5

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 2]

omit:

Risperidone Actavis 2 TA MP NP C1589 C2272 C3083 P3083 60 2

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 5]

omit:

Risperidone Actavis 2 TA MP NP C1589 C2272 C3083 P1589 P2272 60 5

  1. Schedule 1, entry for Risperidone in the form Tablet 3 mg

omit:

Risperidone Actavis 3 TA MP NP C1589 C2272 60 5

  1. Schedule 1, entry for Risperidone in the form Tablet 4 mg

omit:

Risperidone Actavis 4 TA MP NP C1589 C2272 60 5

  1. Schedule 1, entry for Simvastatin in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg

(a) omit:

Simvahexal HX MP C1540 C3047 P1540 30 5
NP C1540 30 5

(b) omit:

Simvahexal HX MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Sodium Chloride

omit:

Injection 9 mg per mL, 10 mL Injection/
solvent for injectables 		Pfizer Australia Pty Ltd PF PDP 5 0
MP NP 5 1

  1. Schedule 1, entry for Somatropin

(a) omit:

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) Injection Norditropin FlexPro NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Norditropin NordiFlex NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Norditropin SimpleXx NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Omnitrope SZ MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D

substitute:

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) Injection Norditropin SimpleXx NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Omnitrope SZ MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Norditropin NordiFlex NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D

(b) omit:

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) Injection Norditropin FlexPro NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Norditropin NordiFlex NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Norditropin SimpleXx NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Omnitrope SZ MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D

substitute:

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) Injection Norditropin SimpleXx NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Omnitrope SZ MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Norditropin NordiFlex NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D

(c) omit:

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) Injection Norditropin FlexPro NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Norditropin NordiFlex NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Norditropin SimpleXx NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D

substitute:

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) Injection Norditropin SimpleXx NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D
Norditropin NordiFlex NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D

  1. Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Sumatriptan-PS FZ MP NP C3233 4 5

  1. Schedule 1, entry for Ticarcillin with Clavulanic Acid

omit from the column headed “Form”:

(with any determined brand of sodium chloride injection as the required solvent)

  1. Schedule 1, entry for Timolol in the form Eye drops 2.5 mg (as maleate) per mL, 5 mL

omit:

Timoptol FR MP AO 1 5

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Max Quantity 30; Number of Repeats 5]

(a) omit:

Valaclovir Actavis 500 TA MP NP C3622 C3623 C3624 C3631 P3623 P3624 30 5

(b) omit from the column headed “Responsible Person” for the brand “Valacor 500”:     QR          substitute: CR

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 0]

(a) omit:

Valaciclovir Actavis 500 TA MP NP C3622 C3623 C3624 C3631 P3622 P3631 42 0

(b) omit from the column headed “Responsible Person” for the brand “Valacor 500”:     QR          substitute: CR

  1. Schedule 1, entry for Verapamil

omit:

Tablet containing verapamil hydrochloride 160 mg Oral Isoptin AB MP NP 60 5

  1. Schedule 3, after details relevant to Responsible person code DO

insert:

DV Medical Developments International Limited  14 106 340 667

  1. Schedule 3

omit:

PZ Prohealth Asia Pacific Pty Ltd  25 076 852 769

  1. Schedule 3

omit:

QR Ranbaxy Australia Pty Limited  17 110 871 826

  1. Schedule 3

omit:

XS Symbion Pty Ltd  25 000 875 034

  1. Schedule 3

omit:

YM Symbion Pty Ltd  25 000 875 034

  1. Schedule 3

omit:

YS Symbion Pty Ltd  25 000 875 034

  1. Schedule 4, Part 1, entry for Calcipotriol

omit:

C2963 Chronic stable plaque type psoriasis vulgaris of the scalp

  1. Schedule 4, Part 1, omit entry for Etidronic Acid

  1. Schedule 4, Part 1, omit entry for Etidronic Acid and Calcium

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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