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: Actrapid Flexpen
Active Ingredient: Neutral insulin, human, pyr 100IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Celapram
Active Ingredient: Citalopram hydrobromide 24.98mg equivalent to 20mg citalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Product: Cromolux
Active Ingredient: Sodium cromoglycate 2%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Tubilux Pharma SpA, Pomezia, Rome, Italy
Product: Dynastat
Active Ingredient: Parecoxib sodium 21.18mg equivalent to 20mg parecoxib
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company
Manufacturers: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Pharmacia, Barceloneta, Puerto Rico
Wasserburger Arzneimittelwerk Dr Madaus GmbH, Wasserburg, Germany
Product: Dynastat
Active Ingredient: Parecoxib sodium 42.36mg equivalent to 40mg parecoxib
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company
Manufacturers: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Pharmacia, Barceloneta, Puerto Rico
Wasserburger Arzneimittelwerk Dr Madaus GmbH, Wasserburg, Germany
Product: NovoMix 30 Flexpen
Active Ingredient: Insulin aspart 100IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Penmix 30 Innolet
Active Ingredients: Isophane insulin, human, pyr 70IU/mL
Neutral insulin, human, pyr 30IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Protaphane Innolet
Active Ingredient: Neutral insulin, human, pyr 100IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Dated this 10th day of February 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).