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-Ropinirole
Active Ingredient: Ropinirole hydrochloride 0.285mg equivalent to 0.25mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Ropinirole
Active Ingredient: Ropinirole hydrochloride 0.57mg equivalent to 0.5mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Ropinirole
Active Ingredient: Ropinirole hydrochloride 1.14mg equivalent to 1mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Ropinirole
Active Ingredient: Ropinirole hydrochloride 2.28mg equivalent to 2mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Ropinirole
Active Ingredient: Ropinirole hydrochloride 3.42mg equivalent to 3mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Ropinirole
Active Ingredient: Ropinirole hydrochloride 4.56mg equivalent to 4mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Ropinirole
Active Ingredient: Ropinirole hydrochloride 5.7mg equivalent to 5mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Bosvate
Active Ingredient: Bisoprolol fumarate 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Chanelle Medical Limited, County Galway, Ireland
Product: Bosvate
Active Ingredient: Bisoprolol fumarate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Chanelle Medical Limited, County Galway, Ireland
Product: Bosvate
Active Ingredient: Bisoprolol fumarate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Chanelle Medical Limited, County Galway, Ireland
Product: Canesten Plus
Active Ingredients: Clotrimazole 10mg/g
Hydrocortisone acetate 11.2mg/g equivalent to hydrocortisone 10mg
Dosage Form: Topical cream
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Kern Pharma SL, Barcelona, Spain
Product: Lamisil Spray
Active Ingredient: Terbinafine hydrochloride 10mg/mL
Dosage Form: Topical spray
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Novartis Consumer Health SA, Nyon, Switzerland
Product: MMF-Panacea Biotec
Active Ingredient: Mycophenolate mofetil 250mg
Dosage Form: Capsule
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Panacea Biotec Limited, Solan Himachal Pradesh, India
Product: Motetis
Active Ingredient: Tetrabenazine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Trommsdorff GmbH & Co. KG Arzneimittel, Alsdorf, Germany
Dated this 26th day of September 2011.
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).