✨ Medicines Distribution Consent




23 DECEMBER 2010 NEW ZEALAND GAZETTE, No. 179 4447

Medicines Act 1981

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: Pradaxa

Active Ingredient: Dabigatran etexilate 86.48mg equivalent to 75mg free base

Dosage Form: Capsule

New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited

Manufacturers:

  • Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
  • Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product: Pradaxa

Active Ingredient: Dabigatran etexilate 126.83mg equivalent to 110mg free base

Dosage Form: Capsule

New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited

Manufacturers:

  • Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
  • Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Dated this 20th day of December 2010.

JANICE WILSON, Deputy Director-General, Population Health 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: Arrow - Ropinirole 0.25

Active Ingredient: Ropinirole hydrochloride 0.285mg equivalent to 0.25mg ropinirole

Dosage Form: Film coated tablet

New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited

Manufacturer: Arrow Laboratories Limited, Croydon, Australia

Product: Arrow - Ropinirole 0.5

Active Ingredient: Ropinirole hydrochloride 0.57mg equivalent to 0.5mg ropinirole

Dosage Form: Film coated tablet

New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited

Manufacturer: Arrow Laboratories Limited, Croydon, Australia

Product: Arrow - Ropinirole 1

Active Ingredient: Ropinirole hydrochloride 1.14mg equivalent to 1mg ropinirole

Dosage Form: Film coated tablet

New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited

Manufacturer: Arrow Laboratories Limited, Croydon, Australia

Product: Arrow - Ropinirole 2

Active Ingredient: Ropinirole hydrochloride 2.28mg equivalent to 2mg ropinirole

Dosage Form: Film coated tablet

New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited

Manufacturer: Arrow Laboratories Limited, Croydon, Australia

Product: m-Pergolide

Active Ingredient: Pergolide mesilate 0.0655mg equivalent to 0.05mg pergolide

Dosage Form: Tablet

New Zealand Sponsor: Multichem NZ Limited

Manufacturer: Pharmathen SA, Attikis, Greece

Product: m-Pergolide

Active Ingredient: Pergolide mesilate 0.3275mg equivalent to 0.25mg pergolide

Dosage Form: Tablet

New Zealand Sponsor: Multichem NZ Limited

Manufacturer: Pharmathen SA, Attikis, Greece



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 179





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of Pradaxa Medicines

πŸ₯ Health & Social Welfare
20 December 2010
Medicines Act 1981, Pradaxa, Dabigatran etexilate, Boehringer Ingelheim
  • Janice Wilson, Deputy Director-General, Population Health Directorate, Ministry of Health

πŸ₯ Consent to Distribution of Arrow-Ropinirole and m-Pergolide Medicines

πŸ₯ Health & Social Welfare
20 December 2010
Medicines Act 1981, Arrow-Ropinirole, m-Pergolide, Arrow Pharmaceuticals, Multichem NZ
  • Janice Wilson, Deputy Director-General, Population Health Directorate, Ministry of Health