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: Tasmar
Active Ingredient: Tolcapone 100mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Note: This consent is given subject to the following conditions:
? The medicine is prescribed only 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; and
? Patients are prescribed the medicine only after informed consent has been obtained.
Note: This consent is valid for two years from 11 December 2004.
Dated this 29th day of September 2004.
GRAEME GILLESPIE, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).