Notice Type
Departmental
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. Dosage Form: Powder for injection. NZ Sponsor: SmithKline Beecham (NZ) Limited. Manufacturer(s): SmithKline Beecham Pharmaceuticals, Worthing, West Sussex, United Kingdom. Product: Gaviscon Double Strength. Active Ingredient(s): Sodium alginate 100 mg/mL. Potassium bicarbonate 20 mg/mL. Dosage Form: Oral suspension. NZ Sponsor: Reckitt & Colman (New Zealand) Limited. Manufacturer(s): Reckitt & Colman Products Limited, Hull, North Humberside, United Kingdom. Product: Rhinocort Aqueous. Active Ingredient(s): Budesonide 32g/dose. Dosage Form: Nasal spray solution. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Production Chemicals AB, Sodertalje, Sweden. Product: Rhinocort Aqueous. Active Ingredient(s): Budesonide 64g/dose. Dosage Form: Nasal spray solution. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Production Chemicals AB, Sodertalje, Sweden. Dated this 9th day of December 1999. G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
Publication Date
16 Dec 1999

Notice Number

1999-go9310

Page Number

4597