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: Entapone
Active Ingredient: Entacapone 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Javlor
Active Ingredient: Vinflunine ditartrate 34.18mg/mL equivalent to vinflunine 25mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: New Zealand Medical & Scientific Limited
Manufacturer: Pierre Fabre Medicament Production, Idron, France
Product: Remifentanil-AFT
Active Ingredient: Remifentanil hydrochloride 1.097mg equivalent to remifentanil 1mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Laboratorio Reig Jofre SA, Barcelona, Spain
Product: Remifentanil-AFT
Active Ingredient: Remifentanil hydrochloride 2.194mg equivalent to remifentanil 2mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Laboratorio Reig Jofre SA, Barcelona, Spain
Product: Remifentanil-AFT
Active Ingredient: Remifentanil hydrochloride 5.485mg equivalent to remifentanil 5mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Laboratorio Reig Jofre SA, Barcelona, Spain
Dated this 26th day of May 2011.
PAT TUOHY, 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).