Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:
Schedule
Product: Clomazol 2%
Active Ingredient: Clotrimazole 20mg/g
Dosage Form: Vaginal cream
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
Product: Kogenate FS
Active Ingredient: Octocog alfa 2,000IU
Dosage Form: Powder for injection
Diluent A
Diluent B
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, California, United States of America
Product: Lamisil Sole Repair
Active Ingredient: Terbinafine hydrochloride 10mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Prangins, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Product: Pradaxa
Active Ingredient: Dabigatran etexilate 126.83mg
Dosage Form: Capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Pradaxa
Active Ingredient: Dabigatran etexilate 86.48mg
Dosage Form: Capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Dated this 12th day of June 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).