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 - Capecitabine
Active Ingredient: Capecitabine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturers: Intas Pharmaceuticals Limited, Gujarat, India
Intas Pharma Limited, Gujarat, India
Product: Arrow - Capecitabine
Active Ingredient: Capecitabine 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturers: Intas Pharmaceuticals Limited, Gujarat, India
Intas Pharma Limited, Gujarat, India
Product: Caverject Impulse
Active Ingredient: Alprostadil 12.8mcg equivalent to maximum dose of 10mcg after reconstitution
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Product: Caverject Impulse
Active Ingredient: Alprostadil 25.6mcg equivalent to maximum dose of 20mcg after reconstitution
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Product: Medical Carbon Dioxide
Active Ingredient: Carbon dioxide 100%
Dosage Form: Gas
New Zealand Sponsor: Air Liquide New Zealand Limited
Manufacturer: Air Liquide New Zealand Limited, Auckland, New Zealand
Dated this 14th day of November 2013.
DR JOHN CRAWSHAW, Acting 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).