✨ Medicines Distribution Consents




8 JANUARY
NEW ZEALAND GAZETTE
39

Product:
Recombinate

Active Ingredient:
Octocog alfa 250IU

Dosage Form:
Powder for injection

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturers:
Baxter Healthcare Corporation, Thousand Oaks, California, United States of America
Baxter Healthcare Corporation, Los Angeles, United States of America

Product:
Recombinate

Active Ingredient:
Octocog alfa 500IU

Dosage Form:
Powder for injection

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturers:
Baxter Healthcare Corporation, Thousand Oaks, California, United States of America
Baxter Healthcare Corporation, Los Angeles, United States of America

Dated this 23rd day of December 2003.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).

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Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
Crestor

Active Ingredient:
Rosuvastatin calcium 10.4mg equivalent to 10mg rosuvastatin

Dosage Form:
Film coated tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturers:
AstraZeneca GmbH, Plankstadt, Germany
IPR Pharmaceuticals Inc, Canovanas, Puerto Rico
IPR Pharmaceuticals Inc, Carolina, Puerto Rico

Product:
Crestor

Active Ingredient:
Rosuvastatin calcium 20.8mg equivalent to 20mg rosuvastatin

Dosage Form:
Film coated tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturers:
AstraZeneca GmbH, Plankstadt, Germany
IPR Pharmaceuticals Inc, Canovanas, Puerto Rico
IPR Pharmaceuticals Inc, Carolina, Puerto Rico

Product:
Crestor

Active Ingredient:
Rosuvastatin calcium 41.6mg equivalent to 40mg rosuvastatin

Dosage Form:
Film coated tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturers:
AstraZeneca GmbH, Plankstadt, Germany
IPR Pharmaceuticals Inc, Canovanas, Puerto Rico
IPR Pharmaceuticals Inc, Carolina, Puerto Rico

Dated this 23rd day of December 2003.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).

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Renewal of Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
Calciferol Strong

Active Ingredient:
Cholecalciferol 1.25mg equivalent to 50,000units

Dosage Form:
Coated tablet

New Zealand Sponsor:
PSM Healthcare Limited

Manufacturer:
PSM Healthcare Limited, Wiri, Auckland

Note: This consent is valid for two years from 10 February 2004.

Dated this 23rd day of December 2003.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).

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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2004, No 1


Gazette.govt.nz PDF NZ Gazette 2004, No 1





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
23 December 2003
Medicines Act, Recombinate, Baxter Healthcare Limited, Octocog alfa
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
23 December 2003
Medicines Act, Crestor, AstraZeneca Limited, Rosuvastatin calcium
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
23 December 2003
Medicines Act, Calciferol Strong, PSM Healthcare Limited, Cholecalciferol
  • DON MATHESON, Deputy Director-General, Public Health