Consent to Distribution of New Medicines




2808 NEW ZEALAND GAZETTE, No. 96 7 JULY 2011

Dated this 30th day of June 2011.

JOHN HOLMES, Acting 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:
Botox®

Active Ingredient:
Botulinum A toxin 100U

Dosage Form:
Powder for injection

New Zealand Sponsor:
Allergan New Zealand Limited

Manufacturer:
Allergan Pharmaceuticals Ireland, County Mayo, Ireland

Product:
Codral Nightime Cold & Flu

Active Ingredients:
Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg

Dosage Form:
Tablet

New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited

Manufacturers:
Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
Janssen-Cilag, Val de Reuil, France

Product:
Nicorette

Active Ingredient:
Nicotine 24.9mg

Dosage Form:
Transdermal patch

New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited

Manufacturer:
McNeil AB, Helsingborg, Sweden

Product:
Nicorette 16hr Invisipatch

Active Ingredient:
Nicotine 23.62mg

Dosage Form:
Transdermal patch

New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited

Manufacturer:
LTS Lohmann Therapie-Systeme AG, Andernach, Germany

Product:
Nicorette 16hr Invisipatch

Active Ingredient:
Nicotine 39.37mg

Dosage Form:
Transdermal patch

New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited

Manufacturer:
LTS Lohmann Therapie-Systeme AG, Andernach, Germany

Product:
Orencia

Active Ingredient:
Abatacept 262.5mg

Dosage Form:
Powder for injection

New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited

Manufacturer:
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico

Product:
Sinutab PE Phenylephrine Sinus, Allergy & Pain Relief

Active Ingredients:
Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to phenylephrine 4.1mg

Dosage Form:
Tablet

New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited

Manufacturer:
Pfizer Laboratories (Pty) Limited, Cape Town, South Africa

Product:
Sudafed PE Phenylephrine Sinus + Allergy & Pain Relief

Active Ingredients:
Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to phenylephrine 4.1mg

Dosage Form:
Tablet

New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited

Manufacturers:
Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
Janssen-Cilag, Val de Reuil, France



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 96





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
30 June 2011
Medicines, Distribution, Consent, Health
  • JOHN HOLMES, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health