Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: GenRx Moclobemide
Active Ingredient: Moclobemide 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: GenRx-Moclobemide
Active Ingredient: Moclobemide 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Note: This consent is valid for 12 months from the date of publication of this notice and is subject to the following condition:
? Apotex NZ Limited provides additional data within nine months from the date of publication of this notice to satisfy me that the packaged product remains efficacious for its stated shelf life.
Dated this 22nd day of September 2009.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).