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: 3TC
Active Ingredient: Lamivudine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom
Product: Berotec
Active Ingredient: Fenoterol hydrobromide 0.1mg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany
Product: Epirubicin Hydrochloride
Active Ingredient: Epirubicin hydrochloride 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Lanacane C
Active Ingredients: Benzocaine 3%w/w
Cetrimide 0.5%w/v
Dosage Form: Topical cream
New Zealand Sponsor: Wilson Foods Limited
Manufacturer: Mentholatum Australasia Pty Limited, Scoresby, Victoria, Australia
Product: One Alpha
Active Ingredient: Alfacalcidol 2Ág/mL
Dosage Form: Oral drops
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer: Leo Pharmaceutical Products Limited A/S, Ballerup, Denmark
Dated this 27th day of September 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).