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: Aspia
Active Ingredient: Aspirin 100mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Marksans Pharma Limited, Goa, India
Product: Biltricide
Active Ingredient: Praziquantel 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Pharma AG, Leverkusen, Germany
Product: Hayfever Relief
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: Kopigra
Active Ingredient: Sildenafil citrate 35.12mg equivalent to sildenafil 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Kopigra
Active Ingredient: Sildenafil citrate 70.24mg equivalent to sildenafil 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Kopigra
Active Ingredient: Sildenafil citrate 140.48mg equivalent to sildenafil 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Rovost
Active Ingredient: Sildenafil citrate 28.096mg equivalent to sildenafil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Scytera
Active Ingredient: Coal tar solution 10%w/w equivalent to coal tar 2%w/w
Dosage Form: Foam
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: DPT Laboratories Limited, Texas, United States of America
Product: Xyntha
Active Ingredient: Moroctocog alfa 3000IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Dated this 6th day of September 2012.
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).