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: Endoxan-Asta
Active Ingredient: Cyclophosphamide (monohydrate) 1,069mg equivalent to 1000mg cyclophosphamide anhydrous
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Asta Medica AG, Halle-Kunsebeck, Germany
Product: Endoxan-Asta
Active Ingredient: Cyclophosphamide (monohydrate) 2,138mg equivalent to 2000mg cyclophosphamide anhydrous
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Asta Medica AG, Halle-Kunsebeck, Germany
Product: Endoxan-Asta
Active Ingredient: Cyclophosphamide (monohydrate) 534.5mg equivalent to 500mg cyclophosphamide anhydrous
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Asta Medica AG, Halle-Kunsebeck, Germany
Product: Oxis Turbuhaler
Active Ingredient: Eformoterol fumarate 12Ág/dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Oxis Turbuhaler
Active Ingredient: Eformoterol fumarate 6Ág/dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Dated this 17th day of April 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).