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-Gabapentin
Active Ingredient: Gabapentin 100mg equivalent to 97.09% w/w
Dosage Form: Capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Arrow-Simva 10
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India
Product: Arrow-Simva 20
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India
Product: Arrow-Simva 40
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India
Product: Arrow-Simva 80
Active Ingredient: Simvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India
Product: Galvus
Active Ingredient: Vildagliptin 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Ganfort
Active Ingredients: Bimatoprost 0.3mg/mL
Timolol maleate 6.8mg/mL equivalent to 5mg/mL timolol
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals Ireland, Westport, County Mayo, Ireland
Product: Losiva
Active Ingredient: Omeprazole 10mg
Dosage Form: Modified release capsule
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Martindale Pharma® Acetylcysteine 200mg/mL Injection
Active Ingredient: Acetylcysteine 20%w/v
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Cardinal Health NZ 217 Limited
Manufacturer: Rotexmedica GmbH, Trittau, Germany
Product: Ropin
Active Ingredient: Ropinirole hydrochloride 0.285mg equivalent to ropinirole 0.25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Torrent Pharmaceuticals Limited, Taluka, Kadi, District Mehsana - Gujarat, India
Product: Ropin
Active Ingredient: Ropinirole hydrochloride 0.57mg equivalent to ropinirole 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Torrent Pharmaceuticals Limited, Taluka, Kadi, District Mehsana - Gujarat, India
Product: Ropin
Active Ingredient: Ropinirole hydrochloride 1.14mg equivalent to ropinirole 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Torrent Pharmaceuticals Limited, Taluka, Kadi, District Mehsana - Gujarat, India
Product: Ropin
Active Ingredient: Ropinirole hydrochloride 2.28mg equivalent to ropinirole 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Torrent Pharmaceuticals Limited, Taluka, Kadi, District Mehsana - Gujarat, India
Product: Ropin
Active Ingredient: Ropinirole hydrochloride 5.7mg equivalent to ropinirole 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Torrent Pharmaceuticals Limited, Taluka, Kadi, District Mehsana - Gujarat, India
Dated this 23rd day of October 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).