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: Colgate Sensitive Multi Protection
Active Ingredients: Potassium citrate monohydrate 5.53%w/w
Sodium monofluorophosphate 0.76%w/w
Zinc citrate 2%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer: Colgate-Palmolive (Thailand) Limited, Amphur Muang, Chonburi, Thailand
Product: Nurofen Period Pain
Active Ingredient: Ibuprofen lysinate 342mg equivalent to 200mg Ibuprofen
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Thane Road, Nottingham, Nottinghamshire, United Kingdom
Product: Peptisoothe
Active Ingredient: Ranitidine hydrochloride 16.8mg/mL equivalent to ranitidine 15mg/mL
Dosage Form: Syrup
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Product: Priorix-Tetra
Active Ingredients: Measles vaccine, Schwarz strain 1,000CCID50
Mumps virus, live attenuated, RIT 4385 10,000CCID50
Rubella virus, Wistar RA27/3 strain 1,000CCID50
Varicella vaccine 1,995PFU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Sachsisches Serumwerk Dresden, Branch of SKB Pharma GmbH, Dresden, Germany
Product: Quetapel
Active Ingredient: Quetiapine fumarate 115.13mg equivalent to quetiapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Merck Farma y Quimica SA, Poligono Merck, Barcelona, Spain
Product: Quetapel
Active Ingredient: Quetiapine fumarate 172.69mg equivalent to quetiapine 150mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Merck Farma y Quimica SA, Poligono Merck, Barcelona, Spain
Product: Quetapel
Active Ingredient: Quetiapine fumarate 230.26mg equivalent to quetiapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Merck Farma y Quimica SA, Poligono Merck, Barcelona, Spain
Product: Quetapel
Active Ingredient: Quetiapine fumarate 28.78mg equivalent to quetiapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Merck Farma y Quimica SA, Poligono Merck, Barcelona, Spain
Product: Quetapel
Active Ingredient: Quetiapine fumarate 345.39mg equivalent to quetiapine 300mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Merck Farma y Quimica SA, Poligono Merck, Barcelona, Spain
Product: DBL® Flumazenil
Active Ingredient: Flumazenil 0.5mg
Dosage Form: Solution for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Product: DBL® Flumazenil
Active Ingredient: Flumazenil 1mg
Dosage Form: Solution for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Dated this 9th day of March 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).