Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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-Alendronate
Active Ingredient: Alendronate sodium trihydrate 13.05mg equivalent to Alendronate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Alendronate
Active Ingredient: Alendronate sodium trihydrate 52.2mg equivalent to Alendronate 40mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Bupropion-AFT
Active Ingredient: Bupropion hydrochloride 150mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Montreal, Canada
Product: Domilium 10
Active Ingredient: Domperidone maleate 12.72mg equivalent to Domperidone 10mg
Dosage Form: Tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Dr Reddy’s Sertraline
Active Ingredient: Sertraline hydrochloride 55.96mg equivalent to Sertraline 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Dr Reddy’s Sertraline
Active Ingredient: Sertraline hydrochloride 111.92mg equivalent to Sertraline 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Oratane
Active Ingredient: Isotretinoin 30mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Swiss Caps AG, Kirchberg, Switzerland
Product: Prokinex
Active Ingredient: Domperidone maleate 12.72mg equivalent to Domperidone 10mg
Dosage Form: Tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Sertraline-DRLA
Active Ingredient: Sertraline hydrochloride 55.96mg equivalent to Sertraline 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Sertraline-DRLA
Active Ingredient: Sertraline hydrochloride 111.92mg equivalent to Sertraline 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Victrelis
Active Ingredient: Boceprevir 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Schering-Plough Limited, Singapore City, Singapore
Dated this 19th day of July 2012.
DR DON MACKIE, 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).