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: Avelox IV 400
Active Ingredient: Moxifloxacin hydrochloride 436.8mg equivalent to 400mg moxifloxacin
Dosage Form: Solution for infusion
New Zealand Sponsor: Bayer New Zealand Limited Health Care Division
Manufacturer: Bayer AG, Bayerwerk, Leverkusen 1, Germany
Product: Difflam-C Anti-inflammatory Antiseptic Solution
Active Ingredient(s): Benzydamine hydrochloride 0.15%w/v
Chlorhexidine gluconate 0.12%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: 3M Pharmaceuticals (a division of 3M New Zealand Limited)
Manufacturer: 3M Pharmaceuticals (Australia) Pty Limited, Thornleigh, New South Wales, Australia
Product: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Product: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Dated this 23rd day of January 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).