Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health, under the provisions of section 24 (5) of the Act, and is set out in the Schedule hereto:
Schedule
Product: Actilyse
Active Ingredient: Alteplase 10mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Actilyse
Active Ingredient: Alteplase 20mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Actilyse
Active Ingredient: Alteplase 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Dated this 8th day of October 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).