14 SEPTEMBER 2006

NEW ZEALAND GAZETTE, No. 107

3187

Dated this 7th day of September 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).
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Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
Coumadin

Active Ingredient:
Warfarin sodium 1mg

Dosage Form:
Tablet

New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics

Manufacturer:
The Boots Company Plc., Beeston, Nottingham, Nottinghamshire, United Kingdom

Note: This consent is given subject to the following condition:
● Not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent.

Note: This consent is valid for two years from the date of publication of this notice.

Product:
Coumadin

Active Ingredient:
Warfarin sodium 2mg

Dosage Form:
Tablet

New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics

Manufacturer:
The Boots Company Plc., Beeston, Nottingham, Nottinghamshire, United Kingdom

Note: This consent is given subject to the following condition:
● Not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent.

Note: This consent is valid for two years from the date of publication of this notice.

Product:
Coumadin

Active Ingredient:
Warfarin sodium 5mg

Dosage Form:
Tablet

New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics

Manufacturer:
The Boots Company Plc., Beeston, Nottingham, Nottinghamshire, United Kingdom

Note: This consent is given subject to the following condition:
● Not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent.

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 7th day of September 2006.
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 in an injection or eye preparation, to any concentration of that medicine; and

(ii) if the medicine is not in an injection or eye preparation, only if the concentration of the medicine or the concentration of the total active principles 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

Amphotericin
Anagrelide
Azatadine; except when specified elsewhere in this Schedule
Brompheniramine; except when specified elsewhere in this Schedule
Brugmansia spp
Chlorpheniramine; except when specified elsewhere in this Schedule
Dexchlorpheniramine; except when specified elsewhere in this Schedule
Dimenhydrinate; except when specified elsewhere in this Schedule
Diphenhydramine; except when specified elsewhere in this Schedule