✨ Medicines Classification and Consent




16 DECEMBER NEW ZEALAND GAZETTE

4597

Schedule 2

Restricted Medicines

clotrimazole; for vaginal use
econazole; for vaginal use
folinic acid (leucovorin)
isoconazole; for vaginal use
leucovorin (folinic acid)
miconazole; for vaginal use
nystatin; for vaginal use
tioconazole; for vaginal use

Schedule 3

Pharmacy-only Medicines

azelaic acid; for dermal use
chloroform; in medicines other than for anaesthesia containing more than 0.5%
cresols; in medicines containing more than 3%
dextromethorphan; in liquid form containing more than 0.25% and not more than 0.3% and in solid dose form containing more than 15 milligrams and not more than 30 milligrams per dose form.
ether; in medicines other than for anaesthesia containing more than 10%
mercury; in topical preparations containing 0.5% or less
oxetacaine; for internal use
phenol; in medicines other than for injection containing more than 3%

xylenols; in medicines containing more than 3%

Medicines for General Sale

Please note that the following medicines are no longer classified as prescription medicines, restricted medicines or pharmacy-only medicines. As such, they are now available for general sale:

chloral hydrate; in topical preparations containing 2% or less
chloroform; in medicines other than for anaesthesia containing 0.5% or less
cresols; in medicines containing 3% or less
dextromethorphan; in liquid form containing 0.25% or less and in solid dose form containing 15 milligrams or less per dose form
edetic acid; in preparations containing dicobalt edetate for the treatment of cyanide poisoning
ether; in medicines other than for anaesthesia containing 10% or less
phenol; in medicines other than for injection containing 3% or less
xylenols; in medicines containing 3% or less

Dated this 9th day of December 1999.

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

99275

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 medicine set out in the Schedule hereto:

Schedule

Product: Flameril.
Active Ingredient(s): Diclofenac sodium 25 mg.
Dosage Form: Enteric coated tablet.
NZ Sponsor: Novartis New Zealand Limited.
Manufacturer(s): Laboratorio Normal Produtos Farmaceuticos SA, Alto do Forte, Casais de Mem Martins, Rio de Mouro, Portugal.

Product: Flameril.
Active Ingredient(s): Diclofenac sodium 50 mg.
Dosage Form: Enteric coated tablet.
NZ Sponsor: Novartis New Zealand Limited.
Manufacturer(s): Laboratorio Normal Produtos Farmaceuticos SA, Alto do Forte, Casais de Mem Martins, Rio de Mouro, Portugal.

Product: Floxapen.
Active Ingredient(s): Flucloxacillin sodium 1088 mg equivalent to 1000 mg flucloxacillin free acid.
Dosage Form: Powder for injection.
NZ Sponsor: SmithKline Beecham (NZ) Limited.
Manufacturer(s): SmithKline Beecham Pharmaceuticals, Worthing, West Sussex, United Kingdom.

Product: Floxapen.
Active Ingredient(s): Flucloxacillin sodium 272 mg equivalent to 250 mg Flucloxacillin free acid.
Dosage Form: Powder for injection.
NZ Sponsor: SmithKline Beecham (NZ) Limited.
Manufacturer(s): SmithKline Beecham Pharmaceuticals, Worthing, West Sussex, United Kingdom.

Product: Floxapen.
Active Ingredient(s): Flucloxacillin sodium 544 mg equivalent to 500 mg Flucloxacillin free acid.



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✨ LLM interpretation of page content

πŸ₯ Classification of Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
9 December 1999
Medicines Classification, Prescription Medicines, Restricted Medicines, Pharmacy-Only Medicines, General Sale Medicines
  • G. R. Boyd, Chief Adviser, Safety and Regulation

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution Consent, Flameril, Floxapen, Diclofenac Sodium, Flucloxacillin Sodium