Notice Type
Departmental
Notice Title

Consent to the Distribution of Changed Medicines

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: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Product: Epaxal Berna
Active Ingredient: Hepatitis A vaccine 500RIA U
Dosage Form: Suspension for injection
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer: Berna Biotech AG, Berne, Switzerland
Product: Norditropin PenSet 12
Active Ingredient: Somatropin 12IU
Dosage Form: Powder for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Ltd
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: Norditropin PenSet 24
Active Ingredient: Somatropin 24IU
Dosage Form: Powder for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: Norditropin Simplexx
Active Ingredient: Somatropin 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Gentofte, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Norditropin Simplexx
Active Ingredient: Somatropin 3.3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Gentofte, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Norditropin Simplexx
Active Ingredient: Somatropin 6.7mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Gentofte, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Norditropin
Active Ingredient: Somatropin 4IU/mL
Dosage Form: Powder for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: Norditropin
Active Ingredient: Somatropin 12IU
Dosage Form: Powder for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Dated this 23rd day of December 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).