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: Aldecin Hayfever. Active Ingredient(s): Beclomethasone dipropionate 0.42 mg/g equivalent to 50 g/dose. Dosage Form: Nasal spray solution. NZ Sponsor: Schering-Plough Pty Limited. Manufacturer(s): Schering-Plough Pty Limited, Baulkham Hills, New South Wales, Australia. Product: Bambec. Active Ingredient(s): Bambuterol hydrochloride 1 mg/mL. Dosage Form: Oral suspension. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden. Product: Bambec. Active Ingredient(s): Bambuterol hydrochloride 10 mg. Dosage Form: Tablet. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden. Product: Bambec. Active Ingredient(s): Bambuterol hydrochloride 20 mg. Dosage Form: Tablet. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden. Product: CEC Suspension. Active Ingredient(s): Cefaclor (monohydrate) 26.22 mg/mL equivalent to 25 mg/mL cefaclor. Dosage Form: Oral suspension. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): allphamed Pharmaceuticals Company Pty Limited, Gottingen, Germany. Product: CEC Suspension. Active Ingredient(s): Cefaclor (monohydrate) 52.44 mg/mL equivalent to 50 mg/mL cefaclor. Dosage Form: Oral suspension. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): allphamed Pharmaceuticals Company Pty Limited, Gottingen, Germany. Product: Clotrihexal. Active Ingredient(s): Clotrimazole 100 mg. Dosage Form: Vaginal tablet. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany. Product: Clotrihexal. Active Ingredient(s): Clotrimazole 200 mg. Dosage Form: Vaginal tablet. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany. Product: Clotrihexal. Active Ingredient(s): Clotrimazole 500 mg. Dosage Form: Vaginal tablet. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany. Product: Cyclohexal. Active Ingredient(s): Cyclosporin 100 mg. Dosage Form: Soft gelatin capsule. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): Salutas Pharma GmbH, Barleben, Germany. Product: Cyclohexal. Active Ingredient(s): Cyclosporin 25 mg. Dosage Form: Soft gelatin capsule. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): Salutas Pharma GmbH, Barleben, Germany. Product: Cyclohexal. Active Ingredient(s): Cyclosporin 50 mg. Dosage Form: Soft gelatin capsule. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): Salutas Pharma GmbH, Barleben, Germany. Product: Cyclohexal. Active Ingredient(s): Cyclosporin 100 mg/mL. Dosage Form: Oral solution. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): Salutas Pharma GmbH, Barleben, Germany. Product: Flameril Retard. Active Ingredient(s): Diclofenac sodium 100 mg. Dosage Form: Modified release 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 Retard. Active Ingredient(s): Diclofenac sodium 75 mg. Dosage Form: Modified release 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: Risperdal. Active Ingredient(s): Risperidone 0.25 mg. Dosage Form: Film coated tablet. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Janssen Pharmaceutica NV, Plant 2, Beerse, Belgium. Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, Latina, Italy. Product: Risperdal. Active Ingredient(s): Risperidone 0.5 mg. Dosage Form: Film coated tablet. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Janssen Pharmaceutica NV, Plant 2, Beerse, Belgium. Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, Latina, Italy. Product: Vancomycin. Active Ingredient(s): Vancomycin hydrochloride 1030 mg equivalent to 1000 mg vancomycin. Dosage Form: Powder for infusion. NZ Sponsor: Pacific Pharmaceuticals Limited. Manufacturer(s): Lipha SA, Le Pressoir Vert, Semoy, France. Product: Vancomycin. Active Ingredient(s): Vancomycin hydrochloride 515 mg equivalent to 500 mg vancomycin. Dosage Form: Powder for infusion. NZ Sponsor: Pacific Pharmaceuticals Limited. Manufacturer(s): Lipha SA, Le Pressoir Vert, Semoy, France. Dated this 1st day of December 1999. S. S. JESSAMINE, Acting Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
Publication Date
9 Dec 1999

Notice Number

1999-go9170

Page Number

4475