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-Zopiclone
Active Ingredient(s): Zopiclone 7.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: OxyContin
Active Ingredient(s): Oxycodone hydrochloride 10mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
P F Laboratories Inc, Totawa, New Jersey, United States of America
Product : OxyContin
Active Ingredient(s): Oxycodone hydrochloride 20mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
P F Laboratories Inc, Totawa, New Jersey, United States of America
Product: OxyContin
Active Ingredient(s): Oxycodone hydrochloride 40mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
P F Laboratories Inc, Totawa, New Jersey, United States of America
Product: OxyContin
Active Ingredient(s): Oxycodone hydrochloride 80mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
P F Laboratories Inc, Totawa, New Jersey, United States of America
Product: OxyNorm
Active Ingredient(s): Oxycodone hydrochloride 10mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Product: OxyNorm
Active Ingredient(s): Oxycodone hydrochloride 20mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Product: OxyNorm
Active Ingredient(s): Oxycodone hydrochloride 5mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Dated this 1st day of February 2001.
GILLIAN GREW, Acting Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the
20th day of February 1997).