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: Alphamox 125
Active Ingredient: Amoxicillin trihydrate 26.2mg/mL equivalent to Amoxicillin 25mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India
Product: Alphamox 250
Active Ingredient: Amoxicillin trihydrate 52.4mg/mL equivalent to Amoxicillin 50mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India
Product: Benlysta
Active Ingredient: Belimumab 120mg
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Hospira Inc, Kansas, United States of America
Product: Benlysta
Active Ingredient: Belimumab 400mg
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Hospira Inc, Kansas, United States of America
Product: Clobetasol Cream
Active Ingredient: Clobetasol propionate 0.5mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Tiofarma B.V, Oud-Beijerland, The Netherlands
Product: Clobetasol Ointment
Active Ingredient: Clobetasol propionate 0.5mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Tiofarma B.V, Oud-Beijerland, The Netherlands
Product: DermAssist
Active Ingredient: Hydrocortisone acetate 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore
Product: Herceptin SC
Active Ingredient: Trastuzumab 120mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Product: Indomethacin Agila
Active Ingredient: Indometacin sodium trihydrate 1.061mg equivalent to Indomethacin 1mg
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Agila Specialties Pvt Limited, Bangalore, India
Product: Indomethacin IV Mylan
Active Ingredient: Indometacin sodium trihydrate 1.061mg equivalent to Indomethacin 1mg
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Agila Specialties Pvt Limited, Bangalore, India
Dated this 25th day of September 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).