✨ Medicines Distribution Consent




5 JULY 2012 NEW ZEALAND GAZETTE, No. 79 2159

Schedule

Product:
Afinitor
Active Ingredient:
Everolimus 2.5mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturers:
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma AG, Stein, Switzerland

Product:
Apo-Montelukast
Active Ingredient:
Montelukast sodium 4.16mg equivalent to montelukast 4mg
Dosage Form:
Chewable tablet
New Zealand Sponsor:
Apotex NZ Limited
Manufacturer:
Apotex Research Private Limited, Bangalore, India

Product:
Apo-Montelukast
Active Ingredient:
Montelukast sodium 5.2mg equivalent to montelukast 5mg
Dosage Form:
Chewable tablet
New Zealand Sponsor:
Apotex NZ Limited
Manufacturer:
Apotex Research Private Limited, Bangalore, India

Product:
Artelac NighttimeGel
Active Ingredient:
Carbomer 2mg/g
Dosage Form:
Ophthalmic gel
New Zealand Sponsor:
Bausch & Lomb (NZ) Limited
Manufacturer:
Dr Gerhard Mann Chem-Pharm Fabrik GmbH, Berlin, Germany

Product:
Eviplera
Active Ingredients:
Emtricitabine 200mg
Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine free base 25mg
Tenofovir disoproxil fumarate 300mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Gilead Sciences (NZ)
Manufacturer:
Patheon Inc, Ontario, Canada

Dated this 27th day of June 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).

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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:
Afinitor
Active Ingredient:
Everolimus 5mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturers:
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

Product:
Afinitor
Active Ingredient:
Everolimus 10mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturers:
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

Dated this 27th day of June 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).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2012, No 79





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
27 June 2012
Medicines Act, New Medicines, Distribution Consent, Afinitor, Apo-Montelukast, Artelac NighttimeGel, Eviplera
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
27 June 2012
Medicines Act, New Medicines, Distribution Consent, Afinitor
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health