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: Atacand
Active Ingredient: Candesartan cilexetil 16mg
Dosage Form: Tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Atacand
Active Ingredient: Candesartan cilexetil 4mg
Dosage Form: Tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Atacand
Active Ingredient: Candesartan cilexetil 8mg
Dosage Form: Tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Femara
Active Ingredient: Letrozole 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Infanrix
Active Ingredients: Detoxified pertussis toxin 25Ág
Diphtheria toxoid, adsorbed 30IU
Pertactin 8Ág
Pertussis filamentous haemagglutinin 25Ág
Tetanus toxoid, adsorbed 40IU
Dosage Form: Vaccine suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Sachsisches Serumwerk Dresden, Dresden, Germany
Product: Infanrix-Hib vaccine
Active Ingredients: Detoxified pertussis toxin 25Ág
Diphtheria toxoid, adsorbed 30IU
Pertactin 8Ág
Pertussis filamentous haemagglutinin 25Ág
Tetanus toxoid 40IU
Dosage Form: Suspension for injection
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10Ág
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Product: Mirena
Active Ingredient: Levonorgestrel 52mg
Dosage Form: Intrauterine contraceptive device
New Zealand Sponsor: Schering (NZ) Limited
Manufacturer: Schering Oy, Turku, Finland
Dated this 9th day of December 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).