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: Apo-Primidone
Active Ingredient: Primidone 250mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Note: This consent is valid for two years from 1 November 2005.
Product: Bicillin L-A
Active Ingredient: Benzathine benzylpenicillin tetrahydrate 450mg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Wyeth Pharmaceuticals Inc, West Chester, Pennsylvania, United States of America
Note: This consent is valid for two years from 18 December 2005.
Product: Herceptin
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche AG, Basel, Switzerland
Note: This consent is valid for two years from 10 January 2006.
Product: Herceptin
Active Ingredient: Trastuzumab 440mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche AG, Basel, Switzerland
Genentech Inc, South San Francisco, California, United States of America
Note: This consent is valid for two years from 8 November 2005.
Product: Rapamune
Active Ingredient: Sirolimus 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Note: This consent is valid for two years from 26 June 2005.
Dated this 28th day of October 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).