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: Apo-Fluoxetine
Active Ingredient(s): Fluoxetine hydrochloride 22.4mg equivalent to 20mg fluoxetine
Dosage Form: Capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: Edetate Disodium 150
Active Ingredient(s): Disodium edetate (anhydrous) 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Centre for Advanced Medicine
Manufacturer(s): Biomed Limited, Pt Chevalier, Auckland
Product: Optazine
Active Ingredient(s): Naphazoline hydrochloride 0.5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Whitehall Consumer Healthcare (NZ) Limited
Manufacturer(s): Sigma Pharmaceuticals Pty Limited, (Creams and liquids man. site), Clayton, Victoria, Australia
Product: Sancap
Active Ingredient(s): Captopril 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Losan Pharma GmbH, Neuenberg, Germany
Product: Sancap
Active Ingredient(s): Captopril 25mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Losan Pharma GmbH, Neuenberg, Germany
Product: Sancap
Active Ingredient(s): Captopril 50mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Losan Pharma GmbH, Neuenberg, Germany
Product: Siterone
Active Ingredient(s): Cyproterone acetate 50mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer(s): Cipla Limited, Patalganga Industrial Area, District - Raigad (Maharashtra), India
Dated this 15th day of May 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).