Medicines Distribution Consent




7 MAY 2009 NEW ZEALAND GAZETTE, No. 62

Product: Risperidone
Active Ingredient: Risperidone 3mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India

Product: Risperidone
Active Ingredient: Risperidone 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India

Product: Sprycel
Active Ingredient: Dasatinib 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America

Product: Sprycel
Active Ingredient: Dasatinib 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America

Product: Sprycel
Active Ingredient: Dasatinib 70mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America

Product: Water for Injections Freeflex
Active Ingredient: Water for injection 100%
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmatel Fresenius Kabi NZ Limited c/- Fresenius Medical Care Australia NZ Pty Limited
Manufacturer: Fresenius Kabi Norge AS, Berg-i-Østfold, Halden, Norway

Dated this 1st day of May 2009.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, 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 Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following 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: Copaxone
Active Ingredient: Glatiramer acetate 20mg
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Teva Pharmaceutical Industries Limited, (Ikapharm), Kfar Saba, Israel

Product: Multihance
Active Ingredient: Gadobenate dimeglumine 0.529g/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Regional Health Limited
Manufacturers: Bracco SpA., Milano, Italy
Patheon Italia SpA, Ferentino Frosinone, Italy

Dated this 1st day of May 2009.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, 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 2009, No 62





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
1 May 2009
Medicines, Distribution, Consent, Risperidone, Sprycel, Water for Injections Freeflex
  • ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

🏥 Consent to the Distribution of Changed Medicines

🏥 Health & Social Welfare
1 May 2009
Medicines, Distribution, Consent, Copaxone, Multihance
  • ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health