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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Arrow - Ropinirole 0.25
Active Ingredient: Ropinirole hydrochloride 0.285mg equivalent to Ropinirole 0.25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Arrow - Ropinirole 0.5
Active Ingredient: Ropinirole hydrochloride 0.57mg equivalent to Ropinirole 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Arrow - Ropinirole 1
Active Ingredient: Ropinirole hydrochloride 1.14mg equivalent to Ropinirole 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Arrow - Ropinirole 2
Active Ingredient: Ropinirole hydrochloride 2.28mg equivalent to Ropinirole 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Dated this 2nd day of February 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).