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: Apo-Diltiazem CD
Active Ingredient(s): Diltiazem hydrochloride 120mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): TorPharm; a Division of Apotex Inc, Etobicoke, Ontario, Canada
Product: Apo-Diltiazem CD
Active Ingredient(s): Diltiazem hydrochloride 180mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): TorPharm; a Division of Apotex Inc, Etobicoke, Ontario, Canada
Product: Apo-Diltiazem CD
Active Ingredient(s): Diltiazem hydrochloride 240mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): TorPharm; a Division of Apotex Inc, Etobicoke, Ontario, Canada
Product: Apo-Diltiazem CD
Active Ingredient(s): Diltiazem hydrochloride 300mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): TorPharm; a Division of Apotex Inc, Etobicoke, Ontario, Canada
Product: Gengraf
Active Ingredient(s): Cyclosporin 100mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Abbott Laboratories Inc., Specialty Products Division, North Chicago, Illinois, United States
of America
Product: Vioxx
Active Ingredient(s): Rofecoxib 50mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck Manufacturing Division of Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Dated this 21st day of March 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).