✨ Medicines Distribution Consent




NEW ZEALAND GAZETTE, No. 68

26 JUNE 2014

Product:
Striverdi Respimat
Active Ingredient:
Olodaterol hydrochloride 2.7mcg equivalent to Olodaterol 2.5mcg
Dosage Form:
Solution for inhalation
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Zimybe 10/10
Active Ingredients:
Ezetimibe 10mg
Simvastatin 10mg
Dosage Form:
Tablet
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Maharashtra State, India

Product:
Zimybe 10/20
Active Ingredients:
Ezetimibe 10mg
Simvastatin 20mg
Dosage Form:
Tablet
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Maharashtra State, India

Product:
Zimybe 10/40
Active Ingredients:
Ezetimibe 10mg
Simvastatin 40mg
Dosage Form:
Tablet
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Maharashtra State, India

Product:
Zimybe 10/80
Active Ingredients:
Ezetimibe 10mg
Simvastatin 80mg
Dosage Form:
Tablet
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Maharashtra State, India

Dated this 20th day of June 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Consent to the Distribution of New Medicines

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:
Advate
Active Ingredient:
Octocog alfa 250IU
Dosage Form:
Powder for injection with diluent
New Zealand Sponsor:
Baxter Healthcare Limited
Manufacturers:
Hameln Pharmaceuticals GmbH, Hameln, Germany
Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland

Product:
Advate
Active Ingredient:
Octocog alfa 500IU
Dosage Form:
Powder for injection with diluent
New Zealand Sponsor:
Baxter Healthcare Limited
Manufacturers:
Hameln Pharmaceuticals GmbH, Hameln, Germany
Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland

Product:
Advate
Active Ingredient:
Octocog alfa 1000IU
Dosage Form:
Powder for injection with diluent
New Zealand Sponsor:
Baxter Healthcare Limited
Manufacturers:
Hameln Pharmaceuticals GmbH, Hameln, Germany
Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 68





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of Striverdi Respimat

πŸ₯ Health & Social Welfare
20 June 2014
Medicines, Distribution, Striverdi Respimat, Olodaterol hydrochloride, Boehringer Ingelheim
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to Distribution of Zimybe Variants

πŸ₯ Health & Social Welfare
20 June 2014
Medicines, Distribution, Zimybe, Ezetimibe, Simvastatin, Mylan New Zealand Limited
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
Medicines, Distribution, Advate, Octocog alfa, Baxter Healthcare Limited
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health