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: Camptosar Active Ingredient(s): Irinotecan hydrochloride 20mg/mL Dosage Form: Solution for injection NZ Sponsor: Pharmacia & Upjohn Limited Company Manufacturer(s): Pharmacia & Upjohn Company, Kalamazoo, Michigan, United States of America Product: Degas Infant drops Active Ingredient(s): Simethicone 100mg/mL Dosage Form: Oral drops NZ Sponsor: Whitehall Laboratories (NZ) Limited Manufacturer(s): Wyeth Australia Pty Limited, Smithfield,, New South Wales, Australia Product: Ear Clear for Ear Wax Removal Active Ingredient(s): Urea hydrogen peroxide 71.5mg/mL Dosage Form: Ear drops NZ Sponsor: Wilson Consumer Products Manufacturer(s): Milpharma Pty Ltd, Brookvale, New South Wales, Australia Product: Opti-Free Express Active Ingredient(s): Polyquaternium - 1 0.001% Myristamidopropyl dimethylamine 0.0005% Dosage Form: Contact lens solution NZ Sponsor: Pacific Pharmaceuticals Limited Manufacturer(s): Alcon Laboratories Inc, Fort Worth, Texas, United States of America Product: ReNu MultiPlus Rewetting Drops Active Ingredient(s): Povidone 1.25% Dosage Form: Contact lens solution NZ Sponsor: Bausch and Lomb (NZ) Limited Manufacturer(s): Bausch & Lomb Personal Products Division, , South Carolina, United States of America Product: Rezulin Active Ingredient(s): Troglitazone 200mg Dosage Form: Film coated tablet NZ Sponsor: Parke Davis (Div. Warner Lambert NZ Ltd) Manufacturer(s): Warner Lambert Inc., Vega Baja, Puerto Rico Product: Rezulin Active Ingredient(s): Troglitazone 400mg Dosage Form: Film coated tablet NZ Sponsor: Parke Davis (Div. Warner Lambert NZ Limited) Manufacturer(s): Warner Lambert Inc., Vega Baja, Puerto Rico Product: Tamiflu Active Ingredient(s): Oseltamivir phosphate 98.5mg equivalent to 75mg oseltamivir Dosage Form: Capsule NZ Sponsor: Roche Products (New Zealand) Limited Manufacturer(s): F Hoffmann-La Roche AG, Head Office and manufacturing site, Basle, Switzerland Product: Vioxx Active Ingredient(s): Rofecoxib 2.5mg/mL Dosage Form: Oral suspension NZ Sponsor: Merck Sharp & Dohme (New Zealand) Limited Manufacturer(s): Merck & Co Inc, Merck Manufacturing Division, West Point, Pennsylvania, United States of America Product: Vioxx Active Ingredient(s): Rofecoxib 5mg/mL Dosage Form: Oral suspension NZ Sponsor: Merck Sharp & Dohme (New Zealand) Limited Manufacturer(s): Merck & Co Inc, Merck Manufacturing Division, West Point, Pennsylvania, United States of America Product: Vioxx Active Ingredient(s): Rofecoxib 12.5mg Dosage Form: Tablet NZ Sponsor: Merck Sharp & Dohme (New Zealand) Limited Manufacturer(s): Merck Manufacturing Division of Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico Merck Sharp and Dohme, South Granville, New South Wales, Australia Product: Vioxx Active Ingredient(s): Rofecoxib 25mg Dosage Form: Tablet NZ Sponsor: Merck Sharp & Dohme (New Zealand) Limited Manufacturer(s): Merck Manufacturing Division of Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico Merck Sharp and Dohme, South Granville, New South Wales, Australia Dated this 21st day of January 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.