Medicines Act Notices




NEW ZEALAND GAZETTE, No. 40

5 APRIL 2012

Health

Medicines Act 1981

Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product: Abelcet
Active Ingredient: Amphotericin B 5mg/mL
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Enzon Pharmaceuticals, Inc, Indianapolis, United States of America

Note: This renewed consent is valid for two years from 6 May 2012.

Dated this 29th day of March 2012.

DR PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (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 medicine set out in the Schedule hereto:

Schedule

Product: Binocrit
Active Ingredient: Epoetin alfa 16.8μg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: IDT Biologika GmbH, Dessau Rosslau, Germany

Product: Binocrit
Active Ingredient: Epoetin alfa 84μg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: IDT Biologika GmbH, Dessau Rosslau, Germany

Product: Binocrit
Active Ingredient: Epoetin alfa 336μg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: IDT Biologika GmbH, Dessau Rosslau, Germany

Product: Ferinject
Active Ingredient: Ferric carboxymaltose 180mg equivalent to Iron 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Nycomed GmbH, Singen, Germany

Product: Hospira™ Ceftriaxone Sodium Powder for Injection
Active Ingredient: Ceftriaxone sodium 1.19g equivalent to Ceftriaxone 1g
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Tamil Nadu, India

Product: Hospira™ Ceftriaxone Sodium Powder for Injection
Active Ingredient: Ceftriaxone sodium 2.39g equivalent to Ceftriaxone 2g
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Tamil Nadu, India

Dated this 29th day of March 2012.

DR PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2012, No 40





✨ LLM interpretation of page content

🏥 Renewal of Provisional Consent to the Distribution of a Medicine

🏥 Health & Social Welfare
29 March 2012
Medicines Act, Provisional Consent, Abelcet, Amphotericin B, Healthcare Logistics
  • DR PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
29 March 2012
Medicines Act, Consent, Binocrit, Epoetin alfa, Novartis, Ferinject, Ferric carboxymaltose, Hospira, Ceftriaxone sodium
  • DR PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health