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(s): Tolcapone 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): F Hoffmann-La Roche AG, Basle, Switzerland
Note: This consent is valid for 2 years from 17 December 2000.
This consent is given subject to the following conditions:
(i) The medicine is prescribed only by medical practitioners vocationally registered under the Medical Practitioners
Act 1995 in the branch of internal medicine;
(ii) Patients receiving the medicine undergo baseline liver function tests, followed by fortnightly tests for the first
3 months of treatment and 4-weekly tests thereafter;
(iii) Patients are prescribed the medicine only after informed consent has been obtained.
Dated this 13th day of July 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).