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: Actonel Active Ingredient(s): Risedronate sodium 30mg equivalent to 27.8mg risedronic acid Dosage Form: Film coated tablet New Zealand Sponsor: Aventis Pharma Limited Manufacturer(s): Procter & Gamble Pharmaceuticals, Norwich, New York, United States of America Product: Actonel Active Ingredient(s): Risedronate sodium 5mg equivalent to 4.64mg risedronic acid Dosage Form: Film coated tablet New Zealand Sponsor: Aventis Pharma Limited Manufacturer(s): Procter & Gamble Pharmaceuticals, Norwich, New York, United States of America Product: Bupivacaine Injection BP Active Ingredient(s): Bupivacaine hydrochloride (monohydrate) 2.635mg/mL equivalent to 2.5mg/ml of Bupivacaine Hydrochloride (anhydrous). Dosage Form: Solution for injection New Zealand Sponsor: Pharmacia & Upjohn Limited Company trading as Pharmacia Manufacturer(s): Pharmacia & Upjohn (Perth) Pty Limited, Bentley, Western Australia, Australia Product: Fosamax Active Ingredient(s): Alendronate sodium 91.37mg equivalent to 70mg alendronate free acid Dosage Form: Tablet New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited Manufacturer(s): Merck Sharp & Dohme Quimica de Puerto Rico Inc., Barceloneta, Puerto Rico Merck Sharp & Dohme SpA., Pavia, Italy Product: Malarone Active Ingredient(s): Atovaquone 250mg Proguanil hydrochloride 100mg Dosage Form: Film coated tablet New Zealand Sponsor: Glaxo Wellcome New Zealand Limited Manufacturer(s): Glaxo Wellcome (Canada) Inc., Mississauga, Ontario, Canada Glaxo Wellcome Operations, Temple Hill, Dartford, Kent, United Kingdom Product: Suprefact Depot Active Ingredient(s): Buserelin acetate 6.6mg equivalent to 6.3mg of buserelin Dosage Form: Subcutaneous implant New Zealand Sponsor: Aventis Pharma Limited Manufacturer(s): Hoechst AG, Frankfurt am Main 80, Germany Product: Suprefact Depot Active Ingredient(s): Buserelin acetate 9.9mg equivalent to 9.45mg of buserelin Dosage Form: Subcutaneous implant New Zealand Sponsor: Aventis Pharma Limited Manufacturer(s): Hoechst AG, Frankfurt am Main 80, Germany Dated this 13th day of September 2000. G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).