✨ Medicines Consent Notices




9 APRIL 2009 NEW ZEALAND GAZETTE, No. 48 1157

Medicines Act 1981

Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following 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: Humira Pen
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Ltd
Manufacturers: Aesica Pharmaceuticals Limited, Queenborough, Kent, United Kingdom
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Product: Humira
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Ltd
Manufacturers: Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany

Product: Tracleer
Active Ingredient: Bosentan 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Manufacturer: Patheon Inc, Toronto Region Operations (TRO), Mississauga, Ontario, Canada

Product: Tracleer
Active Ingredient: Bosentan 62.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Manufacturer: Patheon Inc, Toronto Region Operations (TRO), Mississauga, Ontario, Canada

Dated this 6th day of April 2009.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding 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: Duro-Tuss Phenylephrine PE Dry Cough + Nasal Decongestant
Active Ingredients: Phenylephrine hydrochloride 0.667mg/mL
Pholcodine 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: iNova Pharmaceuticals (Australia) Pty Ltd, Thornleigh, New South Wales, Australia

Product: Lamisil Athlete’s Foot
Active Ingredient: Terbinafine hydrochloride 10mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Ltd (New Zealand)
Manufacturers: Novartis Consumer Health SA, Prangins, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany

Dated this 6th day of April 2009.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, 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 2009, No 48





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
6 April 2009
Medicines Act 1981, Consent, Distribution, Changed Medicines
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
6 April 2009
Medicines Act 1981, Consent, Distribution, New Medicines
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health