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: Ketek
Active Ingredient: Telithromycin 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Aventis Pharmaceuticals Inc, Kansas City, Missouri, United States of America
Product: Laxsol
Active Ingredient(s): Docusate sodium 50.69mg equivalent to 50mg docusate anhydrous
Sennosides 8mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Zuellig-Pharma Limited
Manufacturer: Sigma Pharmaceuticals Pty Limited, Croydon, Victoria, Australia
Product: Metvix
Active Ingredient: Methyl aminolevulinate hydrochloride 200mg/g equivalent to 160mg/g methyl aminolevulinate
Dosage Form: Topical cream
New Zealand Sponsor: Health Consulting Group Limited
Manufacturer: Penn Pharmaceuticals Limited, Tredegar, Gwent, United Kingdom
Product: Zanlan
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Agis Industries Limited, Yeruham, Israel
Dated this 31st 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).