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: Apo-Fluoxetine
Active Ingredient: Fluoxetine hydrochloride 11.2mg equivalent to fluoxetine 10mg
Dosage Form: Capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Cyprostat-100
Active Ingredient: Cyproterone acetate 100mg
Dosage Form: Tablet
New Zealand Sponsor: Schering (NZ) Limited
Manufacturer: Schering SA, Lys Lez Lannoy, France
Product: Paracetamol (Amcal)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer: PSM Healthcare Limited, Wiri, Auckland
Dated this 5th day of June 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).