Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Fexofenadine
Active Ingredient: Fexofenadine hydrochloride 120mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Fexofenadine
Active Ingredient: Fexofenadine hydrochloride 180mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Inspra
Active Ingredient: Eplerenone 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, Puerto Rico
Product: Inspra
Active Ingredient: Eplerenone 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, Puerto Rico
Product: Venofer
Active Ingredient: Iron sucrose 540mg/mL equivalent to iron 20mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: ALTANA Pharma AG, Singen, Germany
Dated this 19th day of December 2005.
KAREN MITCHELL, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).