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: Ibavyr
Active Ingredient: Ribavirin 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Clinect NZ Pty Limited c/o Ebos Group Limited
Manufacturer: Pharmascience Inc, Quebec, Canada
Product: Ibavyr
Active Ingredient: Ribavirin 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Clinect NZ Pty Limited c/o Ebos Group Limited
Manufacturer: Pharmascience Inc, Quebec, Canada
Product: Iron - Aid
Active Ingredient: Ferrous fumarate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore
Product: Fasturtec
Active Ingredient: Rasburicase 1.5mg
Dosage Form: Powder for infusion with diluent
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Aventis SpA, Anagni (Frosinone), Italy
Product: MEDIX Pain & Inflammation
Active Ingredient: Ibuprofen 200mg
Dosage Form: Capsule
New Zealand Sponsor: Nova Pharmaceuticals NZ Limited
Manufacturer: Marksans Pharma Limited, Goa, India
Product: MEDIX Period Pain
Active Ingredient: Ibuprofen 200mg
Dosage Form: Capsule
New Zealand Sponsor: Nova Pharmaceuticals NZ Limited
Manufacturer: Marksans Pharma Limited, Goa, India
Product: Veletri
Active Ingredient: Epoprostenol sodium 531mcg equivalent to Epoprostenol 500mcg
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon Italia SpA, Milan, Italy
Product: Veletri
Active Ingredient: Epoprostenol sodium 1.593mg equivalent to Epoprostenol 1.5mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon Italia SpA, Milan, Italy
Product: Water for Injections BP
Active Ingredient: Water for injection 100%v/v
Dosage Form: Solution for injection
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi Espana S.A.U, Barcelona, Spain
Dated this 8th day of August 2014.
SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).