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 Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 113.85mg/mL equivalent to Gemcitabine 100mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturers: Intas Pharmaceuticals Limited, Plot Nos. 457ª-458, Gujarat, India
Intas Pharmaceuticals Limited, Plot Nos. 5/6/7, Gujarat, India
Product: Sulprix
Active Ingredient: Amisulpride 50mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: McDermott Laboratories, t/a Gerard Laboratories, Dublin, Ireland
Product: Sulprix
Active Ingredient: Amisulpride 100mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: McDermott Laboratories, t/a Gerard Laboratories, Dublin, Ireland
Product: Sulprix
Active Ingredient: Amisulpride 200mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: McDermott Laboratories, t/a Gerard Laboratories, Dublin, Ireland
Product: Sulprix
Active Ingredient: Amisulpride 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: McDermott Laboratories, t/a Gerard Laboratories, Dublin, Ireland
Dated this 16th day of April 2014.
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).