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New Zealand Gazette – 2004 – No. 46

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✨ Medicines Classification

NEW ZEALAND GAZETTE, No. 46

29 APRIL 2004

New Zealand Sponsor:
New Zealand Medical & Scientific Limited

Manufacturer:
Beaufour Ipsen Industrie, Dreux, France

Product:
Zometa

Active Ingredient:
Zoledronic acid monohydrate 0.8528mg/mL equivalent to zoledronic acid anhydrous 0.8mg/mL

Dosage Form:
Concentrate for infusion

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer:
Novartis Pharma AG, Stein, Switzerland

Dated this 23rd day of April 2004.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of 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:

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 proportion of 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 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

Adefovir
Amygdalin; at all strengths
Cinacalcet
Collagen; in injections or implantations for tissue augmentation or cosmetic use
Deferiprone
Duloxetine
Efalizumab
Emtricitabine
Enfuvirtide
Epinastine
Ephedra spp; except ephedra navadensis
Everolimus
Hyaluronic acid; in injections or implantations for tissue augmentation or cosmetic use
Hylan polymer; in injections or implantations for tissue augmentation or cosmetic use
Oxedrine; in medicines containing more than 30 milligrams per recommended daily dose
Pegfilgrastim

Schedule 2

Restricted Medicines

Ciclopirox; for dermal use in medicines containing more than 2%

Schedule 3

Pharmacy-only Medicines

Acetylcysteine; for oral use in medicines containing more than 1 gram per recommended daily dose

*Beclomethasone; in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is not greater than 400 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine

*Budesonide; in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is not greater than 400 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine

Ciclopirox; for dermal use in medicines containing 2% or less except in medicines for tinea pedis only

Dextromethorphan; in liquid form containing more than 0.25% or in solid dose form containing more than 15 milligrams per dose form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams

*Fluticasone; in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is not greater than 200 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine

*Ibuprofen; for oral use in liquid form in packs containing not more than 4 grams in medicines which have received the consent of the Minister or the Director-General to their sale as pharmacy-only medicines and which are sold in the manufacturer’s original pack; for oral use in solid dose form containing not more than 200 milligrams per dose form in medicines which have received the consent of the Minister or the Director-General to their sale as pharmacy-only medicines and which are sold in the manufacturer’s original pack; except in packs containing 200 milligrams or less per oral solid dose form and not more than 25 dose units per pack when in medicines which have received the consent of the Minister or the Director-General to their sale as general

VUW Te Waharoa — NZ Gazette 2004, No 46

Gazette.govt.nz — NZ Gazette 2004, No 46

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✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated23 April 2004
KeywordsMedicines, Distribution consent, Medicines Act 1981
👩‍💼 Officials

Don Matheson, Deputy Director-General, Public Health

🏥 Classification of Medicines

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

Don Matheson, Deputy Director-General, Public Health

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