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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Nexavar
Active Ingredient: Sorafenib tosilate 274mg equivalent to Sorafenib 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Healthcare Manufacturing Srl, Milano, Italy
Bayer Pharma AG, Leverkusen, Germany
Product: Remicade
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Schering-Plough Company, County Cork, Ireland
Cilag AG, Schaffhausen, Switzerland
Patheon Italia SpA, Milan, Italy
MSD International GmbH (Singapore Branch), Singapore
Dated this 1st day of May 2014.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister
of Health on 11 September 2013).