✨ Medicine Distribution Consent




20 JUNE 2013 NEW ZEALAND GAZETTE, No. 78 2143

Product: Simpral
Active Ingredient: Pramipexole hydrochloride monohydrate 0.125mg equivalent to pramipexole 0.088mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India

Product: Simpral
Active Ingredient: Pramipexole hydrochloride monohydrate 0.25mg equivalent to pramipexole 0.18mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India

Product: Simpral
Active Ingredient: Pramipexole hydrochloride monohydrate 1mg equivalent to pramipexole 0.7mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India

Product: Zytiga
Active Ingredient: Abiraterone acetate 250mg
Dosage Form: Tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Patheon Inc, Ontario, Canada

Dated this 13th day of June 2013.

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: Actemra
Active Ingredient: Tocilizumab 20mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Chugai Pharmaceutical Co Limited, Tochigi, Japan

Product: Celsentri
Active Ingredient: Maraviroc 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Godecke GmbH, Freiburg, Germany

Product: Celsentri
Active Ingredient: Maraviroc 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Godecke GmbH, Freiburg, Germany

Product: Ritalin
Active Ingredient: Methylphenidate hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Farmaceutica SA, Barcelona, Spain
Novartis Pharma Stein AG, Stein, Switzerland

Product: Ritalin LA
Active Ingredient: Methylphenidate hydrochloride 20mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Alkermes Gainesville LLC, Georgia, United States of America



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 78





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
13 June 2013
Medicines Act 1981, New Medicines, Distribution Consent, Simpral, Zytiga, Actemra, Celsentri, Ritalin
  • 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
Medicines Act 1981, New Medicines, Distribution Consent, Actemra, Celsentri, Ritalin