National Health Act 1953 Determinations under sections 85, 85A and 88 (No. PB 6 of 2007) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

National Health Act 1953

PHARMACEUTICAL BENEFITS

DETERMINATIONS UNDER SECTIONS 85, 85A AND 88

No. PB 6 of 2007

I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to sections 85, 85A and 88 of the National Health Act 1953, hereby make the following Determinations:

1.  These Determinations commence on 1 February 2007.

2. The Determinations (No. PB 47 of 2006) under sections 85, 85A and 88 of the National Health Act 1953 made on 7 November 2006 with effect from 1 December 2006, as amended on 1 December 2006 with effect from 1 January 2007 (No. PB 1 of 2007), are, in these Determinations, referred to as the Principal Determinations.

  1. Paragraph 3 of the Principal Determinations is amended by omitting:

“(c) in relation to ramipril: captopril or enalapril maleate or fosinopril sodium or lisinopril or perindopril arginine or perindopril erbumine or quinapril hydrochloride or trandolapril;”

and substituting:

“(c) in relation to ramipril (pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg): captopril or enalapril maleate or fosinopril sodium or lisinopril or perindopril arginine or perindopril erbumine or quinapril hydrochloride or ramipril  (tablet 1.25 mg or tablet 2.5 mg or tablet 5 mg or capsule 10 mg) or trandolapril;”.

4.  Paragraph 14 of the Principal Determinations is amended by omitting the following details:

Letters Manufacturer's Name
CX Contact Lens Centre Australia Ltd

and substituting:

Letters Manufacturer's Name
CX Contact Lens Centre Australia Pty Ltd

5. Paragraph 14 of the Principal Determinations is further amended by inserting, after the details in respect of the manufacturer Valeant Pharmaceuticals Australasia Pty Ltd, the following details:

Letters Manufacturer's Name
WA Winthrop Pharmaceuticals Division of Sanofi-Aventis Australia Pty Limited

6.  The First Schedule — Part 1 to the Principal Determinations is amended:

(a)in respect of the pharmaceutical benefit Alendronate Sodium tablet equivalent to 70 mg alendronic acid, by omitting the brands “CH”, “GX” and “TW” from the column headed “Brand”;

(b)in respect of the pharmaceutical benefit Atenolol tablet 50 mg, by omitting the brand “HX” from the column headed “Brand” and inserting the brand “SZ” after the brand “SI”;

(c)in respect of the pharmaceutical benefits Carvedilol tablet 3.125 mg, tablet 6.25 mg, tablet 12.5 mg and tablet 25 mg, by inserting the brand “GX” before the brand “MD” in the column headed “Brand”;

(d)by omitting the details in respect of the pharmaceutical benefit Carvedilol pack containing 30 tablets 3.125 mg, 30 tablets 6.25 mg and 10 tablets 12.5 mg;

(e)by inserting, after the details in respect of the pharmaceutical benefit Ciprofloxacin Hydrochloride tablet equivalent to 250 mg ciprofloxacin, the following details:


Name of
pharmaceutical benefit

Form
(strength, type, size, etc.)
Manner of
adminis-tration
Maxi-mum quantity Maximum
number of
repeats


Brand
Ciprofloxacin Hydrochloride Ear drops equivalent to 3 mg ciprofloxacin per mL, 5 mL Application to the ear 1 1 AQ

(f)in respect of the pharmaceutical benefit Citalopram Hydrobromide tablet equivalent to 20 mg citalopram, by omitting the brand “HX” from the column headed “Brand” and inserting the brand “SZ” after the brand “RE”;

(g)in respect of the pharmaceutical benefit Citalopram Hydrobromide tablet equivalent to 40 mg citalopram, by omitting the brand “HX” from the column headed “Brand” and substituting the brand “SZ”;

(h)in respect of the pharmaceutical benefits Doxycycline Monohydrate tablet equivalent to 50 mg doxycycline and tablet equivalent to 100 mg doxycycline, by omitting the brand “HX” from the column headed “Brand” and substituting the brand “SZ”;

  1. in respect of the pharmaceutical benefit Exemestane tablet 25 mg, by omitting the figure “2” from the column headed “Maximum number of repeats” and substituting the figure “5”;

(j)in respect of the pharmaceutical benefits Glimepiride tablet 1 mg, tablet 2 mg, tablet 3 mg and tablet 4 mg, by inserting the brand “SZ” after the brand “ML” in the column headed “Brand”;

(k)by omitting the details in respect of the pharmaceutical benefit Influenza Vaccine (Split Virion) – Inactivated and substituting the following details:


Name of
pharmaceutical benefit

Form
(strength, type, size, etc.)
Manner of
adminis-tration
Maxi-mum quantity Maximum
number of
repeats


Brand
Influenza Vaccine (Split Virion) - Inactivated Injection containing antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 15 micrograms haemagglutinin;
A/Wisconsin/67/2005 (H3N2)-like strain 15 micrograms haemagglutinin;
 B/Malaysia/2506/2004-like strain 15 micrograms haemagglutinin;
 0.5 mL pre-filled syringe
Injection 1 .. AX, CS, GK, SM

(l)in respect of the pharmaceutical benefit Letrozole tablet 2.5 mg, by omitting the figure “2” from the column headed “Maximum number of repeats” and substituting the figure “5”;

(m)in respect of the pharmaceutical benefit Omeprazole tablet 20 mg, by inserting the brand “SL” after the brand “HX” in the column headed “Brand”;

(n)in respect of the pharmaceutical benefit Paroxetine Hydrochloride tablet equivalent to 20 mg paroxetine, by omitting the brand “HX” from the column headed “Brand” and substituting the brand “SZ”;

(o)in respect of the pharmaceutical benefits Ramipril tablet 1.25 mg, tablet 2.5 mg, tablet 5 mg and capsule 10 mg, by inserting the brands “QM” and “WA” after the brand “ML” in the column headed “Brand”;

(p)in respect of the pharmaceutical benefits Ranitidine Hydrochloride tablet equivalent to 150 mg ranitidine and tablet equivalent to 300 mg ranitidine, by inserting the brand “RA” after the brand “HX” and before the brand “SI” in the column headed “Brand”;

(q)in respect of the pharmaceutical benefits Roxithromycin tablet 150 mg and tablet 300 mg, by inserting the brand “HX” after the brand “HP” in the column headed “Brand”;

(r)in respect of the pharmaceutical benefits Sertraline Hydrochloride tablet equivalent to 50 mg sertraline and tablet equivalent to 100 mg sertraline, by omitting the brand “HX” from the column headed “Brand” and inserting the brand “SZ” after the brand “RA”;

(s)in respect of the pharmaceutical benefit Terbinafine Hydrochloride tablet equivalent to 250 mg terbinafine, by omitting the brand “HX” from  the column headed “Brand” and inserting the brand “SZ” after the brand “NV”;

(t)in respect of the pharmaceutical benefit Tobramycin Sulfate injection equivalent to 80 mg tobramycin in 2 mL (with preservative), by omitting the brand “AS” from the column headed “Brand”.

7.  The First Schedule – Part 2 to the Principal Determinations is amended:

(a)in respect of the pharmaceutical benefit Doxycycline Monohydrate tablet equivalent to 100 mg doxycycline (both occurrences), by omitting the brand “HX” from the column headed “Brand” and substituting the brand “SZ”;

(b)in respect of the pharmaceutical benefit Omeprazole tablet 20 mg, by inserting the brand “SL” after the brand “HX” in the column headed “Brand”;

(c)by omitting the details in respect of the pharmaceutical benefits Ramipril tablet 1.25 mg, tablet 2.5 mg, tablet 5 mg and capsule 10 mg.

8. The Third Schedule — Part 1 to the Principal Determinations is amended in respect of the pharmaceutical benefit Doxycycline Monohydrate tablet equivalent to 100 mg doxycycline by omitting the brand “HX” from the column headed “Brand” and substituting the brand “SZ”.

Dated this 5th day of January 2007.

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing

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