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: BYETTA 5
Active Ingredient: Exenatide 250µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: CP Pharmaceuticals Limited, Wrexham, United Kingdom
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product: BYETTA 10
Active Ingredient: Exenatide 250µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: CP Pharmaceuticals Limited, Wrexham, United Kingdom
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product: Orencia
Active Ingredient: Abatacept 262.5mg
Dosage Form: Powder for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product: Velcade
Active Ingredient: Bortezomib 1mg
Dosage Form: Powder for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Ben Venue Laboratories Inc, Ohio, United States of America
Product: Velcade
Active Ingredient: Bortezomib 3.5mg
Dosage Form: Powder for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Ben Venue Laboratories Inc, Ohio, United States of America
Pierre Fabre Medicament Production, Idron, France
BSP Pharmaceuticals SRL, Latina, Italy
Dated this 23rd day of February 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).