Medicines Classification and Consent




NEW ZEALAND GAZETTE

No. 92

Trytophan; in medicines containing more than 100 milligrams per recommended daily dose

Unoprostone

Uracil

Zaleplon

Schedule 2

Restricted Medicines

Inositol nicotinate

Metoclopramide; when compounded with paracetamol in packs of not more than 10 tablets or capsules for the treatment of nausea associated with migraine

Minoxidil; for external use in medicines containing 5% or less

Santonin

Sulfacetamide; for ophthalmic use in medicines containing 10% or less

Schedule 3

Pharmacy-only Medicines

Acetic acid (excluding its salts and derivatives) and preparations containing more than 80 per cent of acetic acid (CH₃COOH)

Benzoyl peroxide; for external use in medicines containing more than 5% and not more than 10%

Etafedrine

8-hydroxyquinoline and its non-halogenated derivatives; except in medicines containing 1% or less of such substances

*Famotidine; in medicines which are sold in the manufacturer’s original pack containing not more than 14 days’ supply

Icodextrin

Injectable medicines; except when specified elsewhere in the Schedule; except for contrast media

Mercuric oxide; for ophthalmic use

Methoxamine; for external use in medicines containing more than 1%

Papaverine; except for injection

Phenelzine

*Ranitidine; in medicines which are sold in the manufacturer’s original pack containing not more than 14 days’ supply

Tymazoline

Zinc chloride; for external use in medicines containing more than 5%

Medicines for General Sale

The following medicines are no longer classified as prescription medicines, restricted medicines or pharmacy-only medicines. They are, therefore, now available for general sale.

Acetrizoate sodium

Alcohol, absolute

Amidotrizoic acid

Aminacrine

Bismuth; for external use in medicines containing 3% or less

Diatrizoic acid

Emetine; in medicines containing 0.2% or less

Gadodiamide

Gadopentetic acid

Gadoteric acid

Injectable medicines which are contrast media

Iodamide

Iodised oil

Iodixanol

Iohexol

Iomeprol

Iopamidol

Iopanoic acid

Iopodic acid

Iopromide

Iothalamic acid

Iotrolan

Iotroxic acid

Ioversol

Ioxaglic acid

Ipecacuanha; in medicines containing 0.2% or less of emetine

Mangafodipir

Methoxamine; for external use in medicines containing 1% or less

Metrizamide

Metrizoic acid

Nicotine; in chewing gum or transdermal patches for smoking cessation

Permethrin; in medicines containing 5% or less

Piroxicam; for external use

Propylthiouracil

Tryptophan; in medicines containing 100 milligrams or less per recommended daily dose

Zinc chloride; for external use in medicines containing 5% or less

Dated this 14th day of August 2000.

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

Regulation 20 of the Medicines Regulations 1984 requires that all medicines sold without a practitioner’s prescription must include a consumer information panel on the label. Further, all material changes to a medicine (including changes to labelling), must be notified to the Director-General of Health in accordance with section 24 of the Medicines Act 1981.

go6122

Consent to the Distribution of a New Medicine

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:
Benadryl Children’s Dry Coughs

Active Ingredient(s):
Pholcodine 1mg/mL

Dosage Form:
Oral solution

New Zealand Sponsor:
Warner-Lambert Consumer Healthcare Pty Limited

Manufacturer(s):
PharmAction Manufacturing Pty Limited, Laverton North, Victoria, Australia



Next Page →



Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2000, No 92


Gazette.govt.nz PDF NZ Gazette 2000, No 92





✨ LLM interpretation of page content

🏥 Classification of Medicines under Medicines Act 1981 (continued from previous page)

🏥 Health & Social Welfare
14 August 2000
Medicines Act 1981, Prescription Medicines, Restricted Medicines, Pharmacy-Only Medicines, Drug Classification, General Sale Medicines
  • G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
Medicines Act 1981, New Medicine Distribution, Benadryl Children’s Dry Coughs, Pholcodine, Warner-Lambert Consumer Healthcare, PharmAction Manufacturing
  • Minister of Health