Pursuant to section 35(1)(a) of the Medicines Act 1981, the Minister of Health hereby suspends consent to the distribution in New Zealand of the following medicines:
Schedule
Product: Avandia
Active Ingredient: Rosiglitazone maleate 1.33mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Product: Avandia
Active Ingredient: Rosiglitazone maleate 2.65mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Product: Avandia
Active Ingredient: Rosiglitazone maleate 5.3mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Product: Avandia
Active Ingredient: Rosiglitazone maleate 10.6mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Product: Avandamet
Active Ingredients: Rosiglitazone maleate 1.33mg
Metformin hydrochloride 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Product: Avandamet
Active Ingredients: Rosiglitazone maleate 2.65mg
Metformin hydrochloride 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Product: Avandamet
Active Ingredients: Rosiglitazone maleate 2.65mg
Metformin hydrochloride 1000mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Product: Avandamet
Active Ingredients: Rosiglitazone maleate 5.3mg
Metformin hydrochloride 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Product: Avandamet
Active Ingredients: Rosiglitazone maleate 5.3mg
Metformin hydrochloride 1000mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
The above notice comes into force on 29 April 2011.
Note: This notice will remain in force until such time as the Minister of Health is satisfied that the benefits of using these medicines outweighs the risks of their use in a specified population group. In that event, a further notice would be issued in the New Zealand Gazette to revoke this suspension.
Dated this 3rd day of February 2011.
BARBARA PHILLIPS, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 20 December 2001 and the Director-General of Health on 18 January 2002).