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: Orgalutran
Active Ingredient: Ganirelix 0.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Note: This consent is valid for two years from 9 November 2002.
Product: Tasmar
Active Ingredient: Tolcapone 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche AG, Basel, Switzerland
This consent is given subject to the following conditions:
? The medicine may only be prescribed by medical practitioners vocationally registered under the Medical Practitioners Act 1995 in the branch of internal medicine.
? Patients receiving the medicine undergo baseline liver function tests, followed by fortnightly tests for the first three months of treatment and four-weekly tests thereafter.
? Patients are prescribed the medicine only after informed consent has been obtained.
Note: This consent is valid for two years from 11 December 2002.
Dated this 25th day of November 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).