Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Fluvax vaccine
Active Ingredients: Influenza virus haemagglutin type A/New Caledonia/20/99 H1N1-like strain 15Ág/dose
Influenza virus haemagglutin B/Sichuan/379/99-like strain 15Ág/dose
Influenza virus haemagglutin type A/Moscow/10/99 H3N2-like strain 15Ág/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer: CSL Limited, Parkville, Victoria, Australia
Product: Losec MUPS
Active Ingredient: Omeprazole magnesium 10.3mg equivalent to 10mg omeprazole
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Losec MUPS
Active Ingredient: Omeprazole magnesium 20.6mg equivalent to 20mg omeprazole
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Losec MUPS
Active Ingredient: Omeprazole magnesium 41.3mg equivalent to 40mg omeprazole
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Saizen 1.33
Active Ingredient: Somatropin 1.33mg equivalent to 4IU
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Industria Farmaceutica Serono SpA., Modugno, Bari, Italy
Laboratoires Serono SA, l'Ouriettaz, Aubonne, Switzerland
Product: Saizen 3.33
Active Ingredient: Somatropin 3.33mg equivalent to 10IU
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Laboratoires Serono SA, l'Ouriettaz, Aubonne, Switzerland
Product: Saizen 8
Active Ingredient: Somatropin 8mg equivalent to 24IU
Dosage Form: Multidose vial Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Du Pont Pharmaceuticals Company, Manati, Puerto Rico
Industria Farmaceutica Serono SpA., Modugno, Bari, Italy
Laboratoire Aguettant, Chantecaille, Champagne, France
Laboratoires Serono SA, l'Ouriettaz, Aubonne, Switzerland
Dated this 15th day of November 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).