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: Cilazapril - AFT
Active Ingredient: Cilazapril monohydrate 1.043mg equivalent to cilazapril 1mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Montreal, Quebec, Canada
Product: Cilazapril - AFT
Active Ingredient: Cilazapril monohydrate 2.608mg equivalent to cilazapril 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Montreal, Quebec, Canada
Product: Cilazapril - AFT
Active Ingredient: Cilazapril monohydrate 5.215mg equivalent to cilazapril 5mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Montreal, Quebec, Canada
Product: DBL® Gemcitabine for Injection
Active Ingredient: Gemcitabine hydrochloride 1138.5mg equivalent to 1000mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India
Product: DBL® Gemcitabine for Injection
Active Ingredient: Gemcitabine hydrochloride 227.7mg equivalent to 200mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India
Product: DBL® Gemcitabine for Injection
Active Ingredient: Gemcitabine hydrochloride 2277mg equivalent to 2000mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India
Product: Gemcitabine Ebewe
Active Ingredient: Gemcitabine hydrochloride 11.39mg/mL equivalent to gemcitabine 10mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Dated this 30th day of November 2008.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).