Medicines Consents




14 JANUARY 2010

NEW ZEALAND GAZETTE, No. 1


63

Medicines Act 1981

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: Apo-Ciclopirox
Active Ingredient: Ciclopirox 8%w/w
Dosage Form: Nail lacquer
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Groupe Parima, Montreal, Quebec, Canada

Product: Clopidogrel
Active Ingredient: Clopidogrel bisulfate 97.875mg equivalent to 75mg clopidogrel
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Product: Mylanta Ranitidine 12 Hour Action
Active Ingredient: Ranitidine hydrochloride 167.5mg equivalent to 150mg ranitidine
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Salutas Pharma GmbH, Barleben, Germany

Product: Pravastatin
Active Ingredient: Pravastatin sodium 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Product: Pravastatin
Active Ingredient: Pravastatin sodium 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Product: Pravastatin
Active Ingredient: Pravastatin sodium 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Product: Pravastatin
Active Ingredient: Pravastatin sodium 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Dated this 7th day of January 2010.

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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Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Cerezyme
Active Ingredient: Imiglucerase-rch 212U
Dosage Form: Powder for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Manufacturer: Genzyme Corporation, Massachusetts, United States of America

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 7th day of January 2010.

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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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 1





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
7 January 2010
Medicines, Consent, Distribution, New Zealand
  • MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

🏥 Provisional Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
7 January 2010
Medicines, Provisional Consent, Distribution, New Zealand
  • MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health