National Health Act 1953 Determinations under sections 85, 85A and 88 (No. PB 1 of 2007) (Cth)

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COMMONWEALTH OF AUSTRALIA

National Health Act 1953

PHARMACEUTICAL BENEFITS

DETERMINATIONS UNDER SECTIONS 85, 85A AND 88

No. PB 1 of 2007

I, JOAN CORBETT, 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 January 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 are, in these Determinations, referred to as the Principal Determinations.

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

Letters Manufacturer's Name
WF MedWatchDog Pty Limited

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

(a) by omitting the following details in respect of the pharmaceutical benefit Bleomycin Sulfate:


Name of
pharmaceutical benefit

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


Brand
Bleomycin Sulfate Powder for injection 15,000 I.U. Injection 10 .. BQ, MX, SI

and substituting:


Name of
pharmaceutical benefit

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


Brand
Bleomycin Sulfate with any determined brand of Sodium Chloride Injection Powder for injection 15,000 I.U. (with required solvent) Injection 10 .. BQ, MX, SI

(b) by omitting the following details in respect of the pharmaceutical benefit Cefepime Hydrochloride:


Name of
pharmaceutical benefit

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


Brand
Cefepime Hydrochloride Powder for injection equivalent to 1 g cefepime Injection 10 .. BQ
Powder for injection equivalent to 2 g cefepime Injection 10 .. BQ

and substituting:


Name of
pharmaceutical benefit

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


Brand
Cefepime Hydrochloride with any determined brand of Sodium Chloride Injection Powder for injection equivalent to 1 g cefepime (with required solvent) Injection 10 .. BQ
Powder for injection equivalent to 2 g cefepime (with required solvent) Injection 10 .. BQ

(c) by omitting the following details in respect of the pharmaceutical benefit Cyclophosphamide:


Name of
pharmaceutical benefit

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


Brand
Cyclophosphamide Powder for injection 500 mg (anhydrous) Injection 2 .. BX
Powder for injection 1 g (anhydrous) Injection 1 .. BX
Powder for injection 2 g (anhydrous) Injection 1 .. BX

and substituting:


Name of
pharmaceutical benefit

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


Brand

Cyclophosphamide with any determined brand of Sodium Chloride Injection

Powder for injection 500 mg (anhydrous) (with required solvent) Injection 2 .. BX
Powder for injection 1 g (anhydrous) (with required solvent) Injection 1 .. BX
Powder for injection 2 g (anhydrous) (with required solvent) Injection 1 .. BX

(d) in respect of the pharmaceutical benefits Fluconazole capsule 50 mg and capsule 200 mg, by inserting the brand “HX” after the brand “AW” and before the brand “MX” in the column headed “Brand”;

(e) in respect of the pharmaceutical benefit Fluconazole capsule 100 mg, by inserting the brand “HX” after the brand “AF” and before the brand “MX” in the column headed “Brand”;

(f) by inserting, after the details in respect of the pharmaceutical benefit Glucose Indicator—Blood, electrode strips, 50 (GlucoMen Sensor), the following details:


Name of
pharmaceutical benefit

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


Brand
Glucose Indicator—Blood Electrode strips, 50 (MWD Pen Sensor Strips) 2 5 WF

(g) by inserting, after the details in respect of the pharmaceutical benefit Glucose Indicator—Blood, electrode strips, 50 (Omnitest EZ), the following details:


Name of
pharmaceutical benefit

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


Brand
Glucose Indicator—Blood Electrode strips, 50 (Omnitest Plus) 2 5 BR

(h) by omitting the details in respect of the pharmaceutical benefit Moxifloxacin Hydrochloride;

(i)  in respect of the pharmaceutical benefits Oxaliplatin powder for I.V. infusion 50 mg and powder for I.V. infusion 100 mg, by inserting the brand “MX” after the brand “IT” and before the brand “SW” in the column headed “Brand”;

(j)  by omitting the following details in respect of the pharmaceutical benefit Ticarcillin Sodium with Potassium Clavulanate:


Name of
pharmaceutical benefit

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


Brand
Ticarcillin Sodium with Potassium Clavulanate Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid Injection 10 .. GK

and substituting:


Name of
pharmaceutical benefit

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


Brand
Ticarcillin Sodium with Potassium Clavulanate with any determined brand of Sodium Chloride Injection Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid (with required solvent) Injection 10 .. GK

5.  The Third Schedule — Part 1 to the Principal Determinations is amended by omitting the following details in respect of the pharmaceutical benefit Ticarcillin Sodium with Potassium Clavulanate:


Name of
pharmaceutical benefit

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


Brand
Ticarcillin Sodium with Potassium Clavulanate Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid Injection 10 .. GK

and substituting:


Name of
pharmaceutical benefit

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


Brand
Ticarcillin Sodium with Potassium Clavulanate with any determined brand of Sodium Chloride Injection Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid (with required solvent) Injection 10 .. GK

Dated this 1st day of December 2006.

JOAN CORBETT

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing

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