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 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: Levemir Flexpen
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Product: Levemir Innolet
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Product: Levemir Penfill
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Product: Priorix-Tetra
Active Ingredients: Measles vaccine, Schwarz strain 1000CCID50
Mumps virus, live attenuated, RIT 4385 25119CCID50
Rubella virus, Wistar RA27/3 strain 1000CCID50
Varicella vaccine 1995PFU
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Dated this 9th day of June 2011.
MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).