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: Apo-Primidone
Active Ingredient: Primidone 250mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Creon Micro
Active Ingredient: Pancreatin 60.12mg
Dosage Form: Modified release granules
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Abbott Products GmbH, Neustadt, Germany
Product: Intragam 10 NF
Active Ingredient: Immunoglobulin G 10%w/v
Dosage Form: Solution for infusion
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Broadmeadows, Australia
Product: Xarelto
Active Ingredient: Rivaroxaban 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Pharma AG, Leverkusen, Germany
Product: Xarelto
Active Ingredient: Rivaroxaban 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Pharma AG, Leverkusen, Germany
Dated this 26th day of July 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).