Consent to Distribution of New Medicines




1686 NEW ZEALAND GAZETTE, No. 58 24 MAY 2012

Product: Loraclear Hayfever Relief
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sigma Laboratories Limited, Goa, India

Product: Nivestim
Active Ingredient: Filgrastim 0.12mg/0.2mL
Dosage Form: Solution for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Zagreb d.o.o, Zagreb, Croatia

Product: Nivestim
Active Ingredient: Filgrastim 0.3mg/0.5mL
Dosage Form: Solution for injection
New Zealand Sponsor: Hospira NZ Ltd
Manufacturer: Hospira Zagreb d.o.o, Zagreb Croatia

Product: Nivestim
Active Ingredient: Filgrastim 0.48mg/0.5mL
Dosage Form: Solution for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Zagreb d.o.o, Zagreb, Croatia

Product: Zarzio
Active Ingredient: Filgrastim 0.3mg/0.5mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: IDT Biologika GmbH, Dessau Rosslau, Germany

Product: Zarzio
Active Ingredient: Filgrastim 0.48mg/0.5mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: IDT Biologika GmbH, Dessau Rosslau, Germany

Dated this 16th day of May 2012.

DR DON MACKIE, 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).

go3073

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: Calsource CA1000
Active Ingredients: Calcium carbonate 1.7g
Calcium lactogluconate 2.263g
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Famar France, Orleans Cedex 2, France
Famar Orleans, Orleans Cedex, France

Product: Olanzapine 2.5mg Tablets
Active Ingredient: Olanzapine 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Product: Olanzapine 5mg Tablets
Active Ingredient: Olanzapine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2012, No 58





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
16 May 2012
Medicines Act, New Medicines, Consent to Distribution, Loraclear, Nivestim, Zarzio, Calsource CA1000, Olanzapine
  • Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health