✨ Medicines Distribution Consents




13 DECEMBER 2012 NEW ZEALAND GAZETTE, No. 148 4407


Health


Medicines Act 1981


Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Elocon
Active Ingredient: Mometasone furoate 0.1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Schering-Plough Laboratories NV, Heist-op-den-Berg, Belgium

Dated this 6th day of December 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 set out in the Schedule hereto:

Schedule

Product: Calvid
Active Ingredients: Calcium carbonate 2500mg
Colecalciferol 22mcg
Dosage Form: Effervescent granules
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: La. Fa. Re. srl, Ercolano, Italy

Product: NeuroTabs
Active Ingredient: Potassium iodate 0.253mg equivalent to iodine 150mcg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Macleods Pharmaceuticals Limited, Daman, India

Product: Solupred
Active Ingredient: Prednisolone sodium phosphate 0.672%w/v equivalent to prednisolone 5mg/ml
Dosage Form: Oral solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Hoe Pharmaceuticals Sdn Bhd, Selangor, Malaysia

Dated this 6th day of December 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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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 which was referred to the Minister of Health under the provisions of Section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Zelboraf
Active Ingredient: Vemurafenib 800mg equivalent to vemurafenib base 240mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche SpA, Milan, Italy
Note: This consent is valid to 16 February 2014.

Dated this 6th day of December 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 148





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a New Medicine - Elocon

πŸ₯ Health & Social Welfare
6 December 2012
Medicines Act 1981, Mometasone furoate, Topical cream, Merck Sharp & Dohme
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines - Calvid, NeuroTabs, Solupred

πŸ₯ Health & Social Welfare
6 December 2012
Medicines Act 1981, Calcium carbonate, Potassium iodate, Prednisolone sodium phosphate, Effervescent granules, Tablets, Oral solution
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of a New Medicine - Zelboraf

πŸ₯ Health & Social Welfare
6 December 2012
Medicines Act 1981, Vemurafenib, Film coated tablet, Provisional consent
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health