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: Concentrated Haemodialysis Solution Formula NGF - Part A (Article No. 2895)
Active Ingredients: Acetic acid 8.4g/L
Calcium chloride dihydrate 6.5g/L
Glucose 34.7g/L
Magnesium chloride hexahydrate 3.6g/L
Sodium chloride 214.8g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care Australia Pty Limited (NZ)
Manufacturer: Fresenius Medical Care Australia Pty Limited, Smithfield, Australia
Product: Hospira™ Ceftazidime
Active Ingredient: Ceftazidime pentahydrate 1.164g equivalent to ceftazidime 1.0g
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Tamil Nadu, India
Product: Hospira™ Ceftazidime
Active Ingredient: Ceftazidime pentahydrate 2.329g equivalent to ceftazidime 2.0g
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Tamil Nadu, India
Product: Orencia
Active Ingredient: Abatacept 125.875mg equivalent to abatacept 125mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product: pms-Bosentan
Active Ingredient: Bosentan monohydrate 62.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, St Laurent, Canada
Product: pms-Bosentan
Active Ingredient: Bosentan monohydrate 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, St Laurent, Canada
Dated this 21st day of March 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).