β¨ 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 —
NZ Gazette 2004, No 1
Gazette.govt.nz —
NZ Gazette 2004, No 1
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of Changed Medicines
(continued from previous page)
π₯ Health & Social Welfare23 December 2003
Medicines Act, Recombinate, Baxter Healthcare Limited, Octocog alfa
- DON MATHESON, Deputy Director-General, Public Health
π₯ Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare23 December 2003
Medicines Act, Crestor, AstraZeneca Limited, Rosuvastatin calcium
- DON MATHESON, Deputy Director-General, Public Health
π₯ Renewal of Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare23 December 2003
Medicines Act, Calciferol Strong, PSM Healthcare Limited, Cholecalciferol
- DON MATHESON, Deputy Director-General, Public Health