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: Doxorubicin Ebewe
Active Ingredient: Doxorubicin hydrochloride 2mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: InterPharma Pty Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Product: Rexclav
Active Ingredients: Amoxycillin sodium 1,060.2mg equivalent to amoxicillin 1000mg
Potassium clavulanate 238.4mg equivalent to clavulanic acid 200mg
Dosage Form: Powder for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Reig Jofre SA, Toledo, Spain
Product: Rexclav
Active Ingredients: Amoxycillin sodium 530.1mg equivalent to amoxicillin 500mg
Potassium clavulanate 119.2mg equivalent to clavulanic acid 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Reig Jofre SA, Toledo, Spain
Product: Velcade
Active Ingredient: Bortezomib 3.5mg
Dosage Form: Powder for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Dated this 24th day of January 2006.
BARRY BORMAN, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).