Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Albumex 20
Active Ingredient(s): Albumin 200g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Albumex 4
Active Ingredient(s): Albumin 40g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Aropax 20
Active Ingredient(s): Paroxetine hydrochloride 2.289mg/mL equivalent to 0.2% w/v paroxetine free base
Dosage Form: Oral suspension
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Liquides Industries, Herouville, St. Clair, France
SmithKline Beecham Pharmaceuticals Limited, Magpie Wood, Manor Royal, Crawley, Sussex, England
Product: Aropax
Active Ingredient(s): Paroxetine hydrochloride 24.9mg equiv to 20mg Paroxetine
Dosage Form: Film coated tablet
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): Les Laboratories Beecham, Mayenne, France
SmithKline Beecham Pharmaceuticals Limited, Magpie Wood, Manor Royal, Crawley, Sussex, England
Product: Brufen
Active Ingredient(s): Ibuprofen 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Knoll Australia Pty Limited
Manufacturer(s): Laboratoires Knoll France SA, Valenciennes Cedex, France
The Boots Company Plc., Beeston, Nottingham, United Kingdom
Product: Eprex
Active Ingredient(s): Epoetin alfa 336Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Product: Teslascan
Active Ingredient(s): Mangafodipir trisodium 0.01mmol/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Nycomed New Zealand Limited
Manufacturer(s): Abbott Laboratories Inc, McPherson, Kansas, United States of America
Nycomed AS Production, Oslo, Norway
Dated this 4th day of October 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).