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: Bicillin L-A
Active Ingredient: Benzathine penicillin, anhydrous 450mg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Division of Wyeth Pharmaceuticals Inc, West Chester, Pennsylvania, United States of America
Note: This consent is valid for two years from the date of publication of this notice.
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 subject to the following conditions:
? Only physicians in hospital practice 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 the date of publication of this notice.
Dated this 12th day of December 2003.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the
6th day of July 2001).