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: Allerfix
Active Ingredient: Sodium cromoglicate 2%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: FDC Limited, District Aurangabad, India
Product: Apo-Pramipexole
Active Ingredient: Pramipexole hydrochloride 0.125mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Pramipexole
Active Ingredient: Pramipexole hydrochloride 0.25mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Pramipexole
Active Ingredient: Pramipexole hydrochloride 0.5mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Pramipexole
Active Ingredient: Pramipexole hydrochloride 1mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Hospira™ Cefoxitin Sodium
Active Ingredient: Cefoxitin sodium 1.051g equivalent to cefoxitin 1g
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Tamil Nadu, India
Product: Incivo
Active Ingredient: Telaprevir 375mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen-Cilag SpA, Latina, Italy
Dated this 4th day of April 2012.
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).