Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:
Schedule
Product: Zyvox
Active Ingredient: Linezolid 20mg/mL
Dosage Form: Granules for oral suspension
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Pharmaceuticals LLC, Arecibo, Puerto Rico
Product: Zyvox
Active Ingredient: Linezolid 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Fresenius Kabi Norge AS, Berg I Ostfold, Halden, Norway
Product: Zyvox
Active Ingredient: Linezolid 400mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Pharmaceuticals LLC, Arecibo, Puerto Rico
Product: Zyvox
Active Ingredient: Linezolid 600mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Pharmaceuticals LLC, Arecibo, Puerto Rico
Dated this 8th day of April 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).