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 medicine set out in the Schedule hereto:
Schedule
Product: Temodal
Active Ingredient(s): Temozolomide 100mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc., Subsidiary Schering-Plough Corp., Iowa City, Iowa, United States of America
This consent is given subject to the following condition:
? For oncologist only use.
Note: This consent is valid for 2 years from 17 December 2000.
Product: Temodal
Active Ingredient(s): Temozolomide 20mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc., Subsidiary Schering-Plough Corp., Iowa City, Iowa, United States of America
This consent is given subject to the following condition:
? For oncologist only use.
Note: This consent is valid for 2 years from 17 December 2000.
Product: Temodal
Active Ingredient(s): Temozolomide 250mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc., Subsidiary Schering-Plough Corp., Iowa City, Iowa, United States of America
This consent is given subject to the following condition:
? For oncologist only use.
Note: This consent is valid for 2 years from 17 December 2000.
Product: Temodal
Active Ingredient(s): Temozolomide 5mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc., Subsidiary Schering-Plough Corp., Iowa City, Iowa, United States of America
This consent is given subject to the following condition:
? For oncologist only use.
Note: This consent is valid for 2 years from 17 December 2000.
Dated this 17th day of January 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).