Consent to the Distribution of a New Medicine 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: Infanrix-HepB. Active Ingredient(s): Tetanus toxoid 80 IU/mL. Hepatitis B vaccine (rDNA) 20 g/mL. Diphtheria toxoid (adsorbed) 60 IU/mL. Detoxified pertussis toxin 50 g/mL. Pertussis filamentous haemagglutinin 50 g/mL. Pertactin 16 g/mL. Dosage Form: Suspension for injection (0.5 mL dose). NZ Sponsor: SmithKline Beecham (NZ) Limited. Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium. Product: Refludan. Active Ingredient(s): Lepirudin 50 mg. Dosage Form: Powder for injection. NZ Sponsor: Hoechst Marion Roussel (NZ) Limited. Manufacturer(s): Chiron Behring GmbH & Co, Marburg, Germany. Product: Sebizole 1%. Active Ingredient(s): Ketoconazole 10.5 mg/mL. Dosage Form: Shampoo. NZ Sponsor: Douglas Pharmaceuticals Limited. Manufacturer(s): Douglas Pharmaceuticals Limited, Manufacturing Division, Henderson, Auckland. Product: Stemgen. Active Ingredient(s): Ancestim 1.875 mg. Dosage Form: Powder for injection. NZ Sponsor: AMGEN New Zealand. Manufacturer(s): Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America. Product: Stemgen. Active Ingredient(s): Ancestim 2.5 mg. Dosage Form: Powder for injection. NZ Sponsor: AMGEN New Zealand. Manufacturer(s): Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America. Dated this 24th day of September 1999. S. S. JESSAMINE, Acting Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).