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: Canesten Fluconazole Capsule
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Canesten Fluconazole Capsule & Clotrimazole Cream Duo (Combination Product)
Canesten Fluconazole Capsule dose:
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
Clotrimazole dose:
Active Ingredient: Clotrimazole 10mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Kern Pharma SL, Barcelona, Spain
Intas Pharmaceuticals Limited, Gujarat, India
Encube Ethicals Private Limited, Goa, India
Product: Eylea
Active Ingredient: Aflibercept 40mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Regeneron Pharmaceuticals Inc, New York, United States of America
Product: Victrelis® Pegatron® Combination Therapy (Combination Product)
Victrelis dose:
Active Ingredient: Boceprevir 200mg
Dosage Form: Capsule
PEG-Intron dose:
Active Ingredient: Peginterferon alfa-2b 50mcg
Dosage Form: Powder for injection with diluent
Rebetol dose:
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Company, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
Schering-Plough (Singapore) Pte Limited, Singapore
MSD International GmbH (Singapore Branch), Singapore
Product: Victrelis® Pegatron® Combination Therapy (Combination Product)
Victrelis dose:
Active Ingredient: Boceprevir 200mg
Dosage Form: Capsule
PEG-Intron dose:
Active Ingredient: Peginterferon alfa-2b 100mcg
Dosage Form: Powder for injection with diluent
Rebetol dose:
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Company, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
Schering-Plough (Singapore) Pte Limited, Singapore
MSD International GmbH (Singapore Branch), Singapore
Product: Victrelis® Pegatron® Combination Therapy (Combination Product)
Victrelis dose:
Active Ingredient: Boceprevir 200mg
Dosage Form: Capsule
PEG-Intron dose:
Active Ingredient: Peginterferon alfa-2b 120mcg
Dosage Form: Powder for injection with diluent
Rebetol dose:
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Company, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
Schering-Plough (Singapore) Pte Limited, Singapore
MSD International GmbH (Singapore Branch), Singapore
Product: Victrelis® Pegatron® Combination Therapy (Combination Product)
Victrelis dose:
Active Ingredient: Boceprevir 200mg
Dosage Form: Capsule
PEG-Intron dose:
Active Ingredient: Peginterferon alfa-2b 150mcg
Dosage Form: Powder for injection with diluent
Rebetol dose:
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Company, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
Schering-Plough (Singapore) Pte Limited, Singapore
MSD International GmbH (Singapore Branch), Singapore
Product: Zoledronate-DRLA
Active Ingredient: Zoledronic acid monohydrate 0.0533mg/mL equivalent to zoledronic acid 0.05mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Gland Pharma Limited, Andhara Pradesh, India
Product: Zoledronate-DRLA
Active Ingredient: Zoledronic acid monohydrate 0.8258mg/mL equivalent to zoledronic acid 0.8mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Gland Pharma Limited, Andhara Pradesh, India
Dated this 7th day of February 2013.
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).