Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Amirol
Active Ingredient: Amitriptyline hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Remedica Limited, Limassol, Cyprus
Product: Amirol
Active Ingredient: Amitriptyline hydrochloride 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Remedica Limited, Limassol, Cyprus
Product: Metformin Generic Health
Active Ingredient: Metformin hydrochloride 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Indoco Remedies Limited, Verna, Goa, India
Product: Metformin Generic Health
Active Ingredient: Metformin hydrochloride 850mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Indoco Remedies Limited, Verna, Goa, India
Product: Sodium Chloride 0.9% Freeflex
Active Ingredient: Sodium chloride 9g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Pharmatel Fresenius Kabi NZ Limited c/o Fresenius Medical Care Australia NZ Pty Limited
Manufacturer: Fresenius Kabi Norge AS, Berg-i-Ostfold, Halden, Norway
Dated this 3rd day of September 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).