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: Metalyse
Active Ingredient(s): Tenecteplase 30mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer(s): Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Product: Metalyse
Active Ingredient(s): Tenecteplase 40mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer(s): Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Product: Metalyse
Active Ingredient(s): Tenecteplase 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer(s): Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Dated this 16th day of October 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).