β¨ Medicines Approval Notices
NEW ZEALAND GAZETTE, No. 147
29 SEPTEMBER 2011
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).
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Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare26 September 2011
Medicines, Approval, Distribution, Apo-Ropinirole, Bosvate, Canesten Plus, Lamisil Spray, MMF-Panacea Biotec, Motetis
- DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
NZ Gazette 2011, No 147