Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Eloxatin
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Aventis Pharma Limited
Manufacturers: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Laboratoires Thissen SA, Braine-L’Alleud, Belgium
Product: Eloxatin
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Laboratoires Thissen SA, Braine-L’Alleud, Belgium
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: NovoMix 30 Penfill
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: NovoRapid FlexPen
Active Ingredient: Insulin aspart 100IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Production S.A.S, Chartres Cedex, France
Product: NovoRapid Penfill
Active Ingredient: Insulin aspart 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Production S.A.S, Chartres Cedex, France
Product: NovoRapid
Active Ingredient: Insulin aspart 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutical Industries Inc., North Carolina, United States of America
Dated this 8th day of December 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).