Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Boston Advance Cleaner
Active Ingredient(s): Alkyl ether sulphates 263.1mg/mL
Ethoxylated alkyl phenol 3.57mg/mL
Dosage Form: Contact lens solution
New Zealand Sponsor: Bausch and Lomb (NZ) Limited
Manufacturer(s): Bausch & Lomb Personal Products Division, Greenville, South Carolina, United States of America
Product: Ioscan
Active Ingredient(s): Diatrizoic Acid dihydrate 378.65mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Regional Health Limited
Manufacturer(s): Surch Australia, Taren Point, New South Wales, Australia
Product: Zytram SR
Active Ingredient(s): Tramadol hydrochloride 100mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Product: Zytram SR
Active Ingredient(s): Tramadol hydrochloride 150mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Product: Zytram SR
Active Ingredient(s): Tramadol hydrochloride 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Product: Zytram SR
Active Ingredient(s): Tramadol hydrochloride 75mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Product: Zytram XL
Active Ingredient(s): Tramadol hydrochloride 150mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Product: Zytram XL
Active Ingredient(s): Tramadol hydrochloride 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Product: Zytram XL
Active Ingredient(s): Tramadol hydrochloride 300mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Product: Zytram XL
Active Ingredient(s): Tramadol hydrochloride 400mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Dated this 19th day of July 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).