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
Product: Sudafed PE Phenylephrine Sinus Day + Night Relief (Combination Product)
Day Tablet
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
Night Tablet
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: Varilrix Vaccine
Active Ingredient: Varicella vaccine 2000PFU
Dosage Form: Solution for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
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).