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: Actrapid
Active Ingredient: Neutral insulin, human, pyr 100IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Product: Actrapid Flexpen
Active Ingredient: Neutral insulin, human, pyr 100IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Novo Nordisk Producao Farmaceutica do Brasil Limiteda, Montes Claros, Brazil
Product: Actrapid Innolet
Active Ingredient: Neutral insulin, human, pyr 100IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Producao Farmaceutica do Brasil Limiteda, Montes Claros, Brazil
Product: Actrapid Penfill
Active Ingredient: Neutral insulin, human, pyr 100IU/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
Novo Nordisk Pharmaceutical Industries Inc, Clayton, United States of America
Novo Nordisk Producao Farmaceutica do Brasil Limiteda, Montes Claros, Brazil
Product: Mixtard 30
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
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Product: Penmix 30 Flexpen
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
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Novo Nordisk Producao Farmaceutica do Brasil Limiteda, Montes Claros, Brazil
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
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Producao Farmaceutica do Brasil Limiteda, Montes Claros, Brazil
Product: Penmix 30 Penfill
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
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Hillerod, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Novo Nordisk Pharmaceutical Industries Inc, Clayton, United States of America
Novo Nordisk Producao Farmaceutica do Brasil Limiteda, Montes Claros, Brazil
Product: Penmix 40 Penfill
Active Ingredients: Isophane insulin, human, pyr 60IU/mL
Neutral insulin, human, pyr 40IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Product: Penmix 50 Penfill
Active Ingredients: Isophane insulin, human, pyr 50IU/mL
Neutral insulin, human, pyr 50IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Product: Protaphane
Active Ingredient: Isophane insulin, human, pyr 100IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Product: Protaphane Flexpen
Active Ingredient: Isophane insulin, human, pyr 100IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Novo Nordisk Producao Farmaceutica do Brasil Limiteda, Montes Claros, Brazil
Product: Protaphane Innolet
Active Ingredient: Isophane insulin, human, pyr 100IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Producao Farmaceutica do Brasil Limiteda, Montes Claros, Brazil
Product: Protaphane Penfill
Active Ingredient: Isophane insulin, human, pyr 100IU/mL
Dosage Form: Suspension 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
Novo Nordisk Pharmaceutical Industries Inc, Clayton, United States of America
Novo Nordisk Producao Farmaceutica do Brasil Limiteda, Montes Claros, Brazil
Dated this 14th day of December 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).