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: Apo-Enalapril
Active Ingredient(s): Enalapril maleate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Ranbaxy Laboratories Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himachal, Pradesh, India
Product: Apo-Enalapril
Active Ingredient(s): Enalapril maleate 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Ranbaxy Laboratories Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himachal, Pradesh, India
Product: Apo-Enalapril
Active Ingredient(s): Enalapril maleate 20mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Ranbaxy Laboratories Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himachal, Pradesh, India
Product: Apo-Enalapril
Active Ingredient(s): Enalapril maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Ranbaxy Laboratories Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himachal, Pradesh, India
Product: First Response Pregnancy Test
Active Ingredient(s): Antibody to HCG hormone 4.2µg
Murine monoclonal antibody to HCG 3.2µg
Dosage Form: Pregnancy test kit
New Zealand Sponsor: Wilson Consumer Products
Manufacturer(s): Princeton Biomeditech Corporation, Monmouth Junction, New Jersey, United States of America
Product: Omezol
Active Ingredient(s): Omeprazole 10mg
Dosage Form: Capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Laboratorios Dr. Esteve SA, Santa Marti, Martorelles, Barcelona, Spain
Product: Omezol
Active Ingredient(s): Omeprazole 20mg
Dosage Form: Capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Laboratorios Dr. Esteve SA, Santa Marti, Martorelles, Barcelona, Spain
Product: Omezol
Active Ingredient(s): Omeprazole 40mg
Dosage Form: Capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Laboratorios Dr. Esteve SA, Santa Marti, Martorelles, Barcelona, Spain
Dated this 10th day of August 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).