Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Avandia
Active Ingredient: Rosiglitazone maleate 5.3mg equivalent to 4mg rosiglitazone
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SB Pharmaco PR Inc, Barrio Certenejas, Cidra, Puerto Rico
Product: Avandia
Active Ingredient: Rosiglitazone maleate 10.6mg equivalent to 8mg rosiglitazone
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SB Pharmaco PR Inc, Barrio Certenejas, Cidra, Puerto Rico
Product: Mabthera
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Ltd, Basel, Switzerland
Genentech Inc, South San Francisco, California, United States of America
Product: Zerit
Active Ingredient: Stavudine 15mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Product: Zerit
Active Ingredient: Stavudine 20mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Product: Zerit
Active Ingredient: Stavudine 30mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Product: Zerit
Active Ingredient: Stavudine 40mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Product: Zerit
Active Ingredient: Stavudine 1mg/mL
Dosage Form: Powder for oral solution
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Dated this 24th day of August 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).