22 JULY 2004

NEW ZEALAND GAZETTE, No. 91

2247

Medicines Act 1981

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product:
Colgate Sensitive Fresh Stripe Fluoride Toothpaste

Active Ingredients:
Potassium nitrate 5%w/w
Sodium monofluorophosphate 0.755%w/w

Dosage Form:
Toothpaste

New Zealand Sponsor:
Colgate-Palmolive Limited

Manufacturer:
Colgate-Palmolive Pty Limited, Labrador, Queensland, Australia

Product:
Imovax Polio

Active Ingredients:
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU

Dosage Form:
Suspension for injection

New Zealand Sponsor:
Aventis Pharma Limited

Manufacturer:
Aventis Pasteur SA, Marcy L’Etoile, France

Product:
Modavigil

Active Ingredient:
Modafinil 100mg

Dosage Form:
Tablet

New Zealand Sponsor:
CSL New Zealand Limited

Manufacturers:
Laboratoires Macors, Auxerre, France
Laboratoires Opodex Industrie, Villeneuve la Garenne (Hauts-de-Seine), France

Dated this 14th day of July 2004.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Classification of Medicines

Pursuant to section 106 (1) of the Medicines Act 1981,
I, Don Matheson, Deputy Director-General, Public Health Directorate, acting under delegated authority, hereby declare the following:

1. The medicines listed in Schedule 1 to this notice are classified as prescription medicines.

2. The medicines listed in Schedule 2 to this notice are classified as restricted medicines.

3. The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.

Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.

Unless specific reference is made otherwise, every reference applies also to medicines that are:

(a) preparations and admixtures containing any proportion of any substance listed in the notice.

(b) salts and esters of any substance listed in the notice.

(c) preparations or extracts of biological materials listed in the notice.

(d) salts or oxides of elements listed in the notice.

Unless specific reference is made otherwise, every reference to a medicine applies:

(i) if the medicine is an injection or eye preparation, to any concentration of that medicine; and

(ii) if the medicine is not an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.

Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol or element unless specifically stated otherwise.

Schedule 1

Prescription Medicines
Aripiprazole
Bevacizumab
Bosentan
Eplerenone
Fenofibrate
Hydroquinone; except in medicines for external use containing 2% or less
Isosorbide dinitrate
Norelgestromin
Octocog alfa
Pemetrexed
Pregabalin
Sevelamer
Strontium ranelate
Tenofovir
Trichloroacetic acid; except for external use in medicines containing 12.5% or less for the treatment of warts other than anogenital warts

Schedule 2

Restricted Medicines
Fluconazole; for oral use in medicines which have received the consent of the Minister or the Director-General to their distribution as restricted medicines and are sold in the manufacturer’s original pack containing 150 milligrams or less as a single dose for the treatment of vaginal candidiasis

Schedule 3

Pharmacy-only Medicines
Hydroquinone; for external use in medicines containing 2% or less except in hair preparations containing 1% or less