Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Schedule
Product: Fentanyl
Active Ingredient: Fentanyl citrate 15.71mg/L equivalent to Fentanyl 10mg/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 23 September 2014.
Product: Fentanyl
Active Ingredient: Fentanyl citrate 31.42mg/L equivalent to Fentanyl 20mg/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 23 September 2014.
Product: Mitomycin for Injection
Active Ingredient: Mitomycin 5mg
Dosage Form: Powder for injection
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Note: This renewed consent is valid for two years from 28 October 2014.
Product: Mitomycin for Injection
Active Ingredient: Mitomycin 20mg
Dosage Form: Powder for injection
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Note: This renewed consent is valid for two years from 28 October 2014.
Dated this 15th day of August 2014.
SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).