Classification of Medicines




NEW ZEALAND GAZETTE, No. 5 20 JANUARY 2011

Codeine; in medicines for oral use, containing not more than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, when combined with 1 or more active ingredients, in such a way that the substance cannot be recovered by readily applicable means or in a yield which would constitute a risk to health, for use as an analgesic and when sold in a pack of not more than 5 days’ supply, approved by the Minister or the Director-General for distribution as a restricted medicine

Famciclovir; in tablets containing 500 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine

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 supplied to a dental professional recognised by the Dental Council of New Zealand

Lansoprazole; in tablets or capsules containing 15 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine

Omeprazole; in tablets or capsules containing 20 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine

Rizatriptan; for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms, when in wafers containing 5 milligrams or less per wafer and when sold in a pack containing not more than 2 wafers approved by the Minister or the Director-General for distribution as a restricted medicine

Staphylococcus aureus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

Streptococcus beta-haemolyticus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

Zolmitriptan; in a prefilled nasal spray device containing not more than 5 milligrams for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms when sold in a pack of not more than 2 devices approved by the Minister or the Director-General for distribution as a restricted medicine

Schedule 3

Pharmacy-only Medicines

Codeine; in medicines for oral use, containing not more than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, when combined with 1 or more active ingredients, in such a way that the substance cannot be recovered by readily applicable means or in a yield which would constitute a risk to health, for the treatment of the symptoms of cough and cold and when sold in a pack of not more than 6 days’ supply approved by the Minister or the Director-General for distribution as a pharmacy-only medicine

Controlled drugs; that are medicines specified in Part 6 of Schedule 3 of the Misuse of Drugs Act 1975; except codeine as specified elsewhere in this notice

Diclofenac; in solid dose form in medicines containing 12.5 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 75 milligrams

Fexofenadine; for oral use; except when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride when sold in a pack approved by the Minister or the Director-General for distribution as a general sale medicine

Fluorides; for internal use in medicines containing 0.5 milligrams or less per dose unit; except in parenteral nutrition replacement preparations; for external use in liquid form in medicines containing 1000 milligrams or less per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as pharmacy-only medicines, except in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride which have been approved by the Minister or the Director-General for distribution as general sale medicines; except when supplied to a dental professional recognised by the Dental Council of New Zealand except in medicines containing 15 milligrams or less per litre or per kilogram

Loperamide; in packs containing not more than 20 tablets or capsules; except in divided solid dosage forms for oral use containing 2 milligrams or less of loperamide per dosage form when sold in a pack containing not more than 8 dosage forms approved by the Minister or the Director-General for distribution as a general sale medicine for the symptomatic treatment of acute non-specific diarrhoea

Sodium nitrite; except when present as an excipient

Stramonium; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids

Medicines for General Sale

Please note that the following medicines are now available for general sale.

Fexofenadine; in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride when sold in a pack approved by the Minister or the Director-General for distribution as a general sale medicine

Heparins; for external use; when present as an excipient

Loperamide; in divided solid dosage forms for oral use containing 2 milligrams or less of loperamide per dosage form when sold in a pack containing not more than 8 dosage forms approved by the Minister or the Director-General for distribution as a general sale medicine for the symptomatic treatment of acute non-specific diarrhoea

Dated this 14th day of January 2011.

BARBARA PHILLIPS, Acting Deputy Director-General,
Population Health Directorate, Ministry of Health.



Next Page →



Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 5





✨ LLM interpretation of page content

🏥 Classification of Medicines (continued from previous page)

🏥 Health & Social Welfare
14 January 2011
Medicines, Classification, Prescription, Restricted, Pharmacy-only
  • BARBARA PHILLIPS, Acting Deputy Director-General, Population Health Directorate, Ministry of Health