Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the schedule hereto:
Schedule
Product: Apo-Sotalol
Active Ingredient(s): Sotalol hydrochloride 160mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: Apo-Sotalol
Active Ingredient(s): Sotalol hydrochloride 80mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: Avandia
Active Ingredient(s): Rosiglitazone maleate 1.33mg equivalent to 1mg rosiglitazone
Dosage Form: Film coated tablet
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SB Pharmaco PR Inc, Bo. Certenejas, Cidra, Puerto Rico
Product: Avandia
Active Ingredient(s): Rosiglitazone maleate 2.65mg equivalent to 2mg rosiglitazone
Dosage Form: Film coated tablet
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SB Pharmaco PR Inc, Bo. Certenejas, Cidra, Puerto Rico
Product: Avandia
Active Ingredient(s): Rosiglitazone maleate 5.3mg equivalent to 4mg rosiglitazone
Dosage Form: Film coated tablet
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SB Pharmaco PR Inc, Bo. Certenejas, Cidra, Puerto Rico
Product: Avandia
Active Ingredient(s): Rosiglitazone maleate 10.6mg equivalent to 8mg rosiglitazone
Dosage Form: Film coated tablet
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SB Pharmaco PR Inc, Bo. Certenejas, Cidra, Puerto Rico
Product: Enahexal
Active Ingredient(s): Enalapril maleate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Hexal New Zealand Limited
Manufacturer(s): GEA Farmaceutisk Fabrik, Frederiksberg, Denmark
Product: Enahexal
Active Ingredient(s): Enalapril maleate 20mg
Dosage Form: Tablet
New Zealand Sponsor: Hexal New Zealand Limited
Manufacturer(s): GEA Farmaceutisk Fabrik, Frederiksberg, Denmark
Product: Enahexal
Active Ingredient(s): Enalapril maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Hexal New Zealand Limited
Manufacturer(s): GEA Farmaceutisk Fabrik, Frederiksberg, Denmark
Dated this 26th day of June 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).