✨ Medicines Distribution Consents




26 NOVEMBER 2009 NEW ZEALAND GAZETTE, No. 171 4135

Product: Zapril
Active Ingredient: Cilazapril monohydrate 0.522mg equivalent to Cilazapril anhydrous 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Etobicoke, Ontario, Canada

Dated this 20th day of November 2009.

MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance 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 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: Duovisc
Active Ingredients: Chondroitin sulfate A 40mg/mL
Sodium hyaluronate 30mg/mL
Dosage Form: Viscoat Solution for injection
Active Ingredient: Sodium hyaluronate 10mg/mL
Dosage Form: Provisc Solution for injection
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium

Product: Glypressin
Active Ingredient: Terlipressin acetate 1mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Ferring GmbH, Kiel, Germany
Rentschler Biotechnologie GmbH, Laupheim, Germany

Product: Provisc
Active Ingredient: Sodium hyaluronate 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium

Product: RotaTeq
Active Ingredients: Rotavirus reassortant strain G1 2200000IU/dose
Rotavirus reassortant strain G2 2800000IU/dose
Rotavirus reassortant strain G3 2200000IU/dose
Rotavirus reassortant strain G4 2000000IU/dose
Rotavirus reassortant strain P1 2300000IU/dose
Dosage Form: Oral suspension
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America

Dated this 20th day of November 2009.

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

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Renewal of Provisional Consent to the Distribution of Medicines

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 medicines set out in the Schedule hereto:

Schedule

Product: Normison
Active Ingredient: Temazepam 10mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Dandenong, Australia

Note: This consent is valid for two years from 24 November 2009.



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2009, No 171





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
20 November 2009
Medicines, Distribution, Zapril, Cilazapril, Mylan
  • MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
20 November 2009
Medicines, Distribution, Duovisc, Glypressin, Provisc, RotaTeq
  • MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of Medicines

πŸ₯ Health & Social Welfare
20 November 2009
Medicines, Provisional Consent, Normison, Temazepam
  • MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health