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: Boostrix-IPV
Active Ingredients: Diphtheria toxoid, adsorbed 2.5Lf U/dose
Pertactin 2.5µg/dose
Pertussis filamentous haemagglutinin 8µg/dose
Pertussis toxoid, adsorbed 8µg/dose
Polio virus type 1 40DAgU/dose
Polio virus type 2 8DAgU/dose
Polio virus type 3 32DAgU/dose
Tetanus toxoid 5Lf U/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Product: Cozaar
Active Ingredient: Losartan potassium 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Product: Hepatyrix
Active Ingredients: Hepatitis A vaccine 1,440EU/mL
Vi capsular polysaccharide of S. typhi ty2 25µg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Sachsisches Serumwerk Dresden, Branch of SKB Pharma GmbH, Dresden, Germany
Product: Menjugate
Active Ingredients: Diphtheria CRM 197 protein conjugate 0µg/dose
Meningococcal oligosaccharide - Group C 10µg/dose
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Chiron Behring GmbH & Co, Marburg, Germany
Chiron Corporation, Emeryville, California, United States of America
Product: Stromectol
Active Ingredient: Ivermectin 3mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme B.V., Haarlem, The Netherlands
Dated this 12th day of August 2005.
GRAEME GILLESPIE, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).