Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Aricept
Active Ingredient: Donepezil hydrochloride 10mg equivalent to 9.12mg donepezil free base
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturers: Pfizer S.A., de Poce-sur-cisse, Amboise Cedex, France
The Boots Company Plc., Beeston, Nottingham, United Kingdom
Product: Aricept
Active Ingredient: Donepezil hydrochloride 5mg equivalent to 4.56mg donepezil free base
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturers: Pfizer S.A., de Poce-sur-cisse, Amboise Cedex, France
The Boots Company Plc., Beeston, Nottingham, United Kingdom
Product: Cervidil
Active Ingredient: Dinoprostone 10mg
Dosage Form: Pessary
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Controlled Therapeutics (Scotland) Limited, 1 Peel Park Campus, East Kilbride, United Kingdom
Product: Isotane 10
Active Ingredient: Isotretinoin 10mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturers: R P Scherer Limited, Blagrove, Swindon, Wiltshire, United Kingdom
R P Scherer SA, Beinheim, France
Product: Isotane 20
Active Ingredient: Isotretinoin 20mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturers: R P Scherer Limited, Blagrove, Swindon, Wiltshire, United Kingdom
R P Scherer SA, Beinheim, France
Product: Isotane 5
Active Ingredient: Isotretinoin 5mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturers: R P Scherer Limited, Blagrove, Swindon, Wiltshire, United Kingdom
R P Scherer SA, Beinheim, France
Dated this 23rd day of December 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).