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: Actilax
Active Ingredient: Lactulose 66%w/v
Dosage Form: Syrup
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Lacsa Pty Limited, Merebank, Durban, South Africa
Product: Flubiclox
Active Ingredient: Flucloxacillin sodium monohydrate 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Istituto Biochimico Italiano Giovanni Lorenzini SpA, Aprilia (LT), Italy
Product: Pharmacare Paracetamol Tablets
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Indoco Remedies Limited, Verna, India
Product: Premia Low 0.3/1.5 Continuous
Active Ingredients: Conjugated oestrogens 0.3mg
Medroxyprogesterone acetate 1.5mg
Dosage Form: Coated tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: Wyeth Medica Ireland, Little Connell, Newbridge, County Kildare, Ireland
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Product: Premia Low 0.45/1.5 Continuous
Active Ingredients: Conjugated oestrogens 0.45mg
Medroxyprogesterone acetate 1.5mg
Dosage Form: Coated tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: Wyeth Medica Ireland, Little Connell, Newbridge, County Kildare, Ireland
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Product: RotaTeq
Active Ingredients: Rotavirus reassortant strain G1 2,200,000IU/dose
Rotavirus reassortant strain G2 2,800,000IU/dose
Rotavirus reassortant strain G3 2,200,000IU/dose
Rotavirus reassortant strain G4 2,000,000IU/dose
Rotavirus reassortant strain P1 2,300,000IU/dose
Dosage Form: Oral suspension
New Zealand Sponsor: Merck Sharp & Dohme (NZ) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Dated this 15th day of March 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).