New Zealand Gazette – 2001 – No. 135

Page 3464

✨ Medicine Approvals and Classifications

NEW ZEALAND GAZETTE

No. 135

Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s):

AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of America
AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom

Product: Vaniqa
Active Ingredient(s): Eflornithine hydrochloride 13.9%
Dosage Form: Topical cream
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Westwood-Squibb Pharmaceuticals Inc, Buffalo, New York, United States of America

Product: Zeldox IM
Active Ingredient(s): Ziprasidone mesylate 40.93mg equivalent to 30mg ziprasidone
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Ben Venue Laboratories Inc, Bedford, Ohio, United States of America

Dated this 29th day of September 2001.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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Classification of Medicines

Pursuant to section 106 (1) of the Medicines Act 1981,
I, G. R. Boyd, Chief Advisor, Public Health Directorate,
acting under delegated authority, hereby declare the following:

The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
The medicines listed in Schedule 2 to this notice are classified as restricted medicines.
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 substance listed in the notice.

(b) Salts and esters of any substance 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 also applies:

(i) in the case of medicines which are injections or eye preparations, to any concentration of that medicine.

(ii) in the case of medicines which are not injections or eye preparations, when 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

Acamprosate
Acetylcysteine; for injection or inhalation
Aconite; except when specified elsewhere in the Schedule
Adiphenine
Agalsidase alfa
Alcohol; for injection in medicines containing more than 20%
Ambucetamide
Ambutonium
Anakinra
Benzilonium
Caspofungin
Clidinium
Cyclizine; for injection
Dienogest
Drospirenone
Ertapenem
Fluorescein; for injection
Glyceryl trinitrate; for injection; for transdermal use; except in medicines containing 100 micrograms or less per litre or per kilogram
Hexocyclium
Hyaluronic acid; for injection
Hydrocyanic acid; except when specified elsewhere in the Schedule; except in medicines containing 1 microgram or less per litre or per kilogram
Isoetarine
Isoprenaline
Isosorbide dinitrate; except for oral use in medicines containing 10 milligrams or less per dose form
Isosorbide mononitrate
Lanreotide
Levonorgestrel; except when used for emergency contraception and when sold by registered nurses or pharmacists recognised by their respective professional bodies as having competency in the field of sexual and reproductive health
Loperamide; in packs containing more than 20 tablets or capsules
Mepenzolate
Methanthelinium
Modafinil
Octatropine
Oxybutynin
Oxyphencyclimine
Oxyphenonium
Penthienate
Phenthimentonium
Pipenzolate
Piperidolate

VUW Te Waharoa — NZ Gazette 2001, No 135

Gazette.govt.nz — NZ Gazette 2001, No 135

The General Assembly Library (on the right) was completed in 1899 and survived the 1907 fire. Now the oldest remaining original Parliament building, still used as the Parliamentary Library.

✨ LLM interpretation of page content

🏥 Medicine Approval: Vaniqa, Zeldox IM (continued from previous page)

Domain🏥 Health & Social Welfare
Dated29 September 2001
KeywordsMedicines Act, Vaniqa, Eflornithine hydrochloride, Zeldox IM, Ziprasidone mesylate, Film coated tablet, Topical cream, Powder for injection
👩‍💼 Officials

G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Classification of Medicines

Domain🏥 Health & Social Welfare
KeywordsMedicines Act, Prescription medicines, Restricted medicines, Pharmacy-only medicines
👩‍💼 Officials

G. R. Boyd, Chief Advisor, Public Health Directorate

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