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:
Product: Thalidomide Pharmion
Active Ingredient: Thalidomide 50mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Penn Pharmaceuticals Limited, Tredegar, Gwent, United Kingdom
Note: This consent is given subject to the following conditions:
? Only members of the Royal Australasian College of Physicians can prescribe Thalidomide.
? Douglas Pharmaceuticals Limited will manage the risk management programme relating to the distribution and use of thalidomide.
Note: This consent is valid for two years from 18 December 2005.
Dated this 5th day of August 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).