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: PecFent
Active Ingredient: Fentanyl citrate 1.57mg/mL equivalent to Fentanyl base 1.0mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: DPT Laboratories Limited, New Jersey, United States of America
Product: PecFent
Active Ingredient: Fentanyl citrate 6.28mg/mL equivalent to Fentanyl base 4.0mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: DPT Laboratories Limited, New Jersey, United States of America
Dated this 20th day of November 2013.
DR JOHN CRAWSHAW, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).