Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Glivec
Active Ingredient(s): Imatinib mesylate 119.5mg equivalent to 100mg imatinib base
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Note: This consent is valid for 2 years from the date of publication of this notice.
Product: Glivec
Active Ingredient(s): Imatinib mesylate 59.75mg equivalent to 50mg imatinib base
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Note: This consent is valid for 2 years from the date of publication of this notice.
Product: Replagal
Active Ingredient(s): Agalsidase alfa 1mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Health Consulting Group Limited
Manufacturer(s): Chesapeake Biological Laboratories Inc., Baltimore, Maryland, United States of America
Note: This consent is valid for 2 years from the date of publication of this notice.
Dated this 10th 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).