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: Arrow - Aripiprazole
Active Ingredient: Aripiprazole 5mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Unichem Laboratories Limited, Ghaziabad, India
Product: Arrow - Aripiprazole
Active Ingredient: Aripiprazole 10mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Unichem Laboratories Limited, Ghaziabad, India
Product: Arrow - Aripiprazole
Active Ingredient: Aripiprazole 15mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Unichem Laboratories Limited, Ghaziabad, India
Product: Arrow - Aripiprazole
Active Ingredient: Aripiprazole 20mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Unichem Laboratories Limited, Ghaziabad, India
Product: Arrow - Aripiprazole
Active Ingredient: Aripiprazole 30mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Unichem Laboratories Limited, Ghaziabad, India
Product: Benztrop
Active Ingredient: Benzatropine mesilate 2mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Quebec, Canada
Product: Capecitabine Winthrop
Active Ingredient: Capecitabine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Remedica Limited, Limassol, Cyprus
Product: Capecitabine Winthrop
Active Ingredient: Capecitabine 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Remedica Limited, Limassol, Cyprus
Product: NicoQuit (Mint)
Active Ingredient: Nicotine polacrilex 14.9mg equivalent to Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: NicoQuit (Mint)
Active Ingredient: Nicotine polacrilex 29.9mg equivalent to Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: NicoQuit (Fruit)
Active Ingredient: Nicotine polacrilex 14.9mg equivalent to Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: NicoQuit (Fruit)
Active Ingredient: Nicotine polacrilex 29.9mg equivalent to Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Fertin Pharma A/S, Vejle Denmark
Dated this 7th day of November 2013.
DR DON MACKIE, 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).