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: 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, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
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, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Actrapid Novolet
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, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
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, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutical Industries, Inc., Clayton, North Carolina, United States of America
Novo Nordisk Pharmaceutique S.A., Chartres Cedex, France
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, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
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, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Mixtard 50
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
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Monotard
Active Ingredient: Neutral insulin, human, pyr 100IU
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Penmix 10 Penfill
Active Ingredients: Isophane insulin, human, pyr 90IU/mL
Neutral insulin, human, pyr 10IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Penmix 10 Novolet
Active Ingredients: Isophane insulin, human, pyr 90IU/mL
Neutral insulin, human, pyr 10IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Penmix 20 Novolet
Active Ingredients: Isophane insulin, human, pyr 80IU/mL
Neutral insulin, human, pyr 20IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Penmix 20 Penfill
Active Ingredients: Isophane insulin, human, pyr 80IU/mL
Neutral insulin, human, pyr 20IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutique S.A., Chartres Cedex, France
Product: Penmix 30 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, Kalundborg, Denmark
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
Manufacturers: Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Penmix 30 Novolet
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, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
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, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutical Industries, Inc., Clayton, North Carolina, United States of America
Novo Nordisk Pharmaceutique S.A., Chartres Cedex, France
Product: Penmix 40 Novolet
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
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
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, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutique S.A., Chartres Cedex, France
Product: Penmix 50 Novolet
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
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
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, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutique S.A., Chartres Cedex, France
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, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Protaphane Innolet
Active Ingredient: Neutral insulin, human, pyr 100IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Protaphane Novolet
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, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
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, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutical Industries, Inc., Clayton, North Carolina, United States of America
Novo Nordisk Pharmaceutique S.A., 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, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Ultratard
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, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Velosulin HM(ge)
Active Ingredient: Insulin, human, recombinant DNA origin 100IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Dated this 14th day of October 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).