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Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23 (4a) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Schedule
Product: Normison
Active Ingredient: Temazepam 10mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Dandenong, Australia
Note: This consent is valid for two years from 24 November 2009.
Product: Rapamune
Active Ingredient: Sirolimus 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Patheon Inc, Toronto Region Operations (TRO), Mississauga, Ontario, Canada
Note: This consent is valid for two years from the date of publication of this notice.
Product: Rapamune
Active Ingredient: Sirolimus 1mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Wyeth Pharmaceutical Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Note: This consent is valid for two years from 22 November 2009.
Product: Rapamune
Active Ingredient: Sirolimus 2mg
Dosage Form: Coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Wyeth Pharmaceutical Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Note: This consent is valid for two years from 12 January 2010.
Dated this 20th day of November 2009.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).