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-Zoledronic Acid
Active Ingredient: Zoledronic acid monohydrate 0.853mg/mL equivalent to Zoledronic acid 0.80mg/ml
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Agila Specialties Polska Sp. z.o.o, Warsaw, Poland
Product: Aripiprazole generichealth
Active Ingredient: Aripiprazole 5mg
Dosage Form: Tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Indoco Remedies Limited, Goa, India
Product: Aripiprazole generichealth
Active Ingredient: Aripiprazole 10mg
Dosage Form: Tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Indoco Remedies Limited, Goa, India
Product: Aripiprazole generichealth
Active Ingredient: Aripiprazole 15mg
Dosage Form: Tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Indoco Remedies Limited, Goa, India
Product: Aripiprazole generichealth
Active Ingredient: Aripiprazole 20mg
Dosage Form: Tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Indoco Remedies Limited, Goa, India
Product: Aripiprazole generichealth
Active Ingredient: Aripiprazole 30mg
Dosage Form: Tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Indoco Remedies Limited, Goa, India
Product: Capercit
Active Ingredient: Capecitabine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy's New Zealand Limited
Manufacturer: Dr Reddy's Laboratories Limited, Andhra Pradesh, India
Product: Capercit
Active Ingredient: Capecitabine 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy's New Zealand Limited
Manufacturer: Dr Reddy's Laboratories Limited, Andhra Pradesh, India
Product: Lyxumia
Active Ingredient: Lixisenatide 0.05mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany
Product: Lyxumia
Active Ingredient: Lixisenatide 0.1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany
Product: Lyxumia (Combination Pack)
Component 1
Active Ingredient: Lixisenatide 0.05mg/mL
Component 2
Active Ingredient: Lixisenatide 0.1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany
Dated this 7th day of March 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).