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: Listerine Antiseptic Mouthwash
Active Ingredients: Benzoic acid 0.12%w/v
Cineole 0.0922%w/v
Ethanol 0.27mL/mL
Thymol 0.0639%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Ensign Laboratories Pty Limited, Mulgrave, Australia
IDS Manufacturing Limited, Pathumthani, Thailand
McNeil Manufacturing Pty Limited, Taren Point, Australia
Product: Listerine Citrus Fresh Antiseptic Mouthwash
Active Ingredients: Benzoic acid 0.115%w/v
Cineole 0.0922%w/v
Ethanol 22.271%v/v
Thymol 0.0639%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Ensign Laboratories Pty Limited, Mulgrave, Australia
Product: Listerine Coolmint Antiseptic Mouthwash
Active Ingredients: Benzoic acid 0.12%w/v
Cineole 0.092%w/v
Ethanol 22%v/v
Thymol 0.064%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Ensign Laboratories Pty Limited, Mulgrave, Australia
IDS Manufacturing Limited, Pathumthani, Thailand
Product: Listerine Freshburst Antiseptic Mouthwash
Active Ingredients: Benzoic acid 0.12%w/v
Cineole 0.0922%w/v
Ethanol 22.57%v/v
Thymol 0.0639%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Ensign Laboratories Pty Limited, Mulgrave, Australia
IDS Manufacturing Limited, Pathumthani, Thailand
McNeil Manufacturing Pty Limited, Taren Point, Australia
Product: Listerine Smooth Mint Antiseptic Mouthwash
Active Ingredients: Benzoic acid 1.2mg/mL
Cineole 0.922mg/mL
Ethanol 0.225mL/mL
Thymol 0.639mg/mL
Dosage Form: Mouthwash
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: McNeil Manufacturing Pty Limited, Caringbah, Australia
Product: Listerine Tartar Control Antiseptic Mouthwash
Active Ingredients: Benzoic acid 0.105%w/v
Cineole 0.092%w/v
Ethanol 22.5%v/v
Thymol 0.064%w/v
Zinc chloride 0.09%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Ensign Laboratories Pty Limited, Mulgrave, Australia
IDS Manufacturing Limited, Pathumthani, Thailand
McNeil Manufacturing Pty Limited, Taren Point, Australia
Product: Listerine Teeth Defence
Active Ingredients: Benzoic acid 1.5mg/mL
Cineole 0.92mg/mL
Ethanol 0.22mL/mL
Sodium fluoride 0.22mg/mL
Thymol 0.64mg/mL
Dosage Form: Mouthwash
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Ensign Laboratories Pty Limited, Mulgrave, Australia
IDS Manufacturing Limited, Pathumthani, Thailand
Product: Ovidrel
Pre-filled syringe
Active Ingredient: Choriogonadotropin alfa 250µg
Dosage Form: Solution for injection
Pen Injector
Active Ingredient: Choriogonadotropin alfa 250µg
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Merck Serono SpA, Bari, Italy
Merck Serono SA, Aubonne, Switzerland
Product: Sprycel
Active Ingredient: Dasatinib 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Indiana, United States of America
Product: Sprycel
Active Ingredient: Dasatinib 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Indiana, United States of America
Product: Sprycel
Active Ingredient: Dasatinib 70mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Indiana, United States of America
Product: Sprycel
Active Ingredient: Dasatinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Indiana, United States of America
Dated this 3rd day of March 2011.
MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).