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-Candesartan
Active Ingredient: Candesartan cilexetil 4mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Candesartan
Active Ingredient: Candesartan cilexetil 8mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Candesartan
Active Ingredient: Candesartan cilexetil 16mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Candesartan
Active Ingredient: Candesartan cilexetil 32mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Finasteride Alphapharm
Active Ingredient: Finasteride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan LLC, Caguas, Puerto Rico
Product: Simpral
Active Ingredient: Pramipexole hydrochloride monohydrate 0.125mg equivalent to pramipexole 0.088mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Simpral
Active Ingredient: Pramipexole hydrochloride monohydrate 0.25mg equivalent to pramipexole 0.18mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Simpral
Active Ingredient: Pramipexole hydrochloride monohydrate 1mg equivalent to pramipexole 0.7mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Zytiga
Active Ingredient: Abiraterone acetate 250mg
Dosage Form: Tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Patheon Inc, Ontario, Canada
Dated this 13th day of June 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).