Health Notices




18 MARCH 2010 NEW ZEALAND GAZETTE, No. 31 855

Health

Medicines Act 1981

Corrigendum—Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health gave his consent to the distribution in New Zealand of the new medicines listed in the Schedule to a notice published in the New Zealand Gazette, 14 January 2010, No. 1, page 63.

This corrigendum amends the notice by revoking the entry for the following new medicine:

Schedule

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

Explanatory Note: This note is not part of the corrigendum but is intended to explain this corrigendum. The revocation of the entry for this medicine is required to correct an administrative error.

Dated this 12th day of March 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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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-Azithromycin
Active Ingredient: Azithromycin dihydrate 522.04mg equivalent to 500mg azithromycin
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India

Product: Apo-Azithromycin
Active Ingredient: Azithromycin dihydrate 261.02mg equivalent to 250mg azithromycin
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India

Product: Nicorette 16hr Invisipatch
Active Ingredient: Nicotine 23.62mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany

Product: Nicorette 16hr Invisipatch
Active Ingredient: Nicotine 39.37mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany

Product: Nicorette 16hr Invisipatch
Active Ingredient: Nicotine 15.75mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany

Product: Nicotinell Classic
Active Ingredient: Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Fertin Pharma A/S, Vejle, Denmark



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 31





✨ LLM interpretation of page content

🏥 Corrigendum—Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
12 March 2010
Medicines, Corrigendum, Revocation, Pravastatin
  • MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
Medicines, Consent, Distribution, Apo-Azithromycin, Nicorette, Nicotinell