✨ Medicine Approval Notices




24 JULY 2014 NEW ZEALAND GAZETTE, No. 79 2201

Product: Tecfidera
Active Ingredient: Dimethyl fumarate 120mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Biogen Idec NZ Limited
Manufacturer: Vifor Pharma, Villars-sur-Glane, Switzerland

Product: Tecfidera
Active Ingredient: Dimethyl fumarate 240mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Biogen Idec NZ Limited
Manufacturer: Vifor Pharma, Villars-sur-Glane, Switzerland

Dated this 17th day of July 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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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: Quetapel
Active Ingredient: Quetiapine fumarate 28.78mg equivalent to Quetiapine 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Merck SL, Barcelona, Spain
Mylan Laboratories Limited, Maharashtra State, India

Product: Quetapel
Active Ingredient: Quetiapine fumarate 115.13mg equivalent to Quetiapine 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Merck SL, Barcelona, Spain
Mylan Laboratories Limited, Maharashtra State, India

Product: Quetapel
Active Ingredient: Quetiapine fumarate 172.69mg equivalent to Quetiapine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Merck SL, Barcelona, Spain
Mylan Laboratories Limited, Maharashtra State, India

Product: Quetapel
Active Ingredient: Quetiapine fumarate 230.26mg equivalent to Quetiapine 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Merck SL, Barcelona, Spain
Mylan Laboratories Limited, Maharashtra State, India

Product: Quetapel
Active Ingredient: Quetiapine fumarate 345.39mg equivalent to Quetiapine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Merck SL, Barcelona, Spain
Mylan Laboratories Limited, Maharashtra State, India

Dated this 17th day of July 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Renewal of Provisional Consent to the Distribution of a Medicine

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 medicine set out in the Schedule hereto:



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 79





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Tecfidera

πŸ₯ Health & Social Welfare
17 July 2014
Medicine Approval, Tecfidera, Dimethyl fumarate, Medsafe, Biogen Idec NZ Limited
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of Quetapel

πŸ₯ Health & Social Welfare
17 July 2014
Medicine Approval, Quetapel, Quetiapine fumarate, Medsafe, Mylan New Zealand Limited
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of a Medicine

πŸ₯ Health & Social Welfare
17 July 2014
Medicine Renewal, Provisional Consent, Medsafe, Ministry of Health
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health