NEW ZEALAND GAZETTE, No. 35

19 MARCH 2009

Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America

Product: Baraclude

Active Ingredient: Entecavir monohydrate 1mg

Dosage Form: Film coated tablet

New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited

Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America

Dated this 13th day of March 2009.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of 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, Anthony Hill, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health, 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 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

Albumin; except human albumin
Alglucosidase
Anidulafungin
Chloramphenicol; except for ophthalmic use when sold in practice by a registered optometrist
Desvenlafaxine

Fluorides; for internal use in medicines containing more than 0.5 milligrams per dose unit except in medicines containing 15 milligrams or less per litre or per kilogram; except in parenteral nutrition replacement preparations; for external use in medicines containing more than 5500 milligrams per litre or per kilogram except when used in practice by a registered dental therapist

Golimumab
Lacosamide
Liraglutide
Nitric oxide
Omeprazole; except when specified elsewhere in this Schedule
Prasugrel
Romiplostim
Rotigotine
Temsirolimus

Schedule 2

Restricted Medicines

Fluorides; for external use in liquid form in medicines containing 5500 milligrams or less and more than 1000 milligrams per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as restricted medicines; for external use in non-liquid form in medicines containing 5500 milligrams or less and more than 1000 milligrams per litre or per kilogram except in medicines containing 1500 milligrams or less and more than 1000 milligrams per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as general sale medicines; except when used in practice by a registered dental therapist

Glyceryl trinitrate; for rectal use

Omeprazole; in tablets or capsules containing 10 milligrams or less and when sold in packs approved by the Minister or the Director-General for distribution as restricted medicines

Schedule 3

Pharmacy-only Medicines

Aloes for internal use; except when obtained solely from the mucilaginous gel of the leaf