Medicines Distribution Consents




4956 NEW ZEALAND GAZETTE, No. 188 4 DECEMBER 2008

Product: Aranesp
Active Ingredient: Darbepoetin alfa 25μg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Amgen Manufacturing Ltd, Juncos, Puerto Rico

Product: Aranesp
Active Ingredient: Darbepoetin alfa 40μg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Amgen Manufacturing Ltd, Juncos, Puerto Rico

Product: Aranesp
Active Ingredient: Darbepoetin alfa 500μg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Amgen Manufacturing Ltd, Juncos, Puerto Rico

Product: Aranesp
Active Ingredient: Darbepoetin alfa 60μg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Amgen Manufacturing Ltd, Juncos, Puerto Rico

Dated this 30th day of November 2008.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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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 set out in the Schedule hereto:

Schedule

Product: Cilazapril - AFT
Active Ingredient: Cilazapril monohydrate 1.043mg equivalent to cilazapril 1mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Montreal, Quebec, Canada

Product: Cilazapril - AFT
Active Ingredient: Cilazapril monohydrate 2.608mg equivalent to cilazapril 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Montreal, Quebec, Canada

Product: Cilazapril - AFT
Active Ingredient: Cilazapril monohydrate 5.215mg equivalent to cilazapril 5mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Montreal, Quebec, Canada

Product: DBL® Gemcitabine for Injection
Active Ingredient: Gemcitabine hydrochloride 1138.5mg equivalent to 1000mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India

Product: DBL® Gemcitabine for Injection
Active Ingredient: Gemcitabine hydrochloride 227.7mg equivalent to 200mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India

Product: DBL® Gemcitabine for Injection
Active Ingredient: Gemcitabine hydrochloride 2277mg equivalent to 2000mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2008, No 188





✨ LLM interpretation of page content

🏥 Consent to the Distribution of a Changed Medicine (Aranesp) (continued from previous page)

🏥 Health & Social Welfare
30 November 2008
Medicines, Distribution, Aranesp, Darbepoetin alfa
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
Medicines, Distribution, Cilazapril, Gemcitabine