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: 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 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, Usine De Mayenne, Mayenne, France
SmithKline Beecham Pharmaceuticals Limited, Magpie Wood, Manor Royal, Crawley, Sussex, England
Dated this 11th day of July 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).