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: Anatrole
Active Ingredient: Anastrozole 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Synthon Hispania SL, Barcelona, Spain
Product: Astromide
Active Ingredient: Temozolomide 5mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Orion Pharma, Turku, Finland
Product: Astromide
Active Ingredient: Temozolomide 20mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Orion Pharma, Turku, Finland
Product: Astromide
Active Ingredient: Temozolomide 100mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Orion Pharma, Turku, Finland
Product: Astromide
Active Ingredient: Temozolomide 140mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Orion Pharma, Turku, Finland
Product: Astromide
Active Ingredient: Temozolomide 180mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Orion Pharma, Turku, Finland
Product: Astromide
Active Ingredient: Temozolomide 250mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Orion Pharma, Turku, Finland
Product: Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 227.7mg equivalent to 200mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 1138.5mg equivalent to 1000mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Jurnista
Active Ingredient: Hydromorphone hydrochloride 8mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, United States of America
Product: Jurnista
Active Ingredient: Hydromorphone hydrochloride 16mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, United States of America
Product: Jurnista
Active Ingredient: Hydromorphone hydrochloride 32mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, United States of America
Product: Jurnista
Active Ingredient: Hydromorphone hydrochloride 64mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, United States of America
Product: Panadol Caplet
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Dungarvan Limited, Waterford, Ireland
GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: Panvax H1N1 vaccine
Active Ingredient: Influenza virus A/California/7/2009 (H1N1) - like strain 15µg
Dosage Form: Suspension for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Parkville, Australia
Product: Risperidone
Active Ingredient: Risperidone 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Dated this 22nd day of April 2010.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).