Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: 5008 bibag for Haemodialysis Solution
Active Ingredient: Sodium bicarbonate 100%w/w
Dosage Form: Powder
New Zealand Sponsor: Fresenius Medical Care Australia Pty Limited
Manufacturer: Fresenius SMAD, Secteur Ouest, Savigny, L’Arbresle Cede, France
Product: Apo-Risperidone
Active Ingredient: Risperidone 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Risperidone
Active Ingredient: Risperidone 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Risperidone
Active Ingredient: Risperidone 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Risperidone
Active Ingredient: Risperidone 3mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Risperidone
Active Ingredient: Risperidone 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Topiramate
Active Ingredient: Topiramate 100mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Apo-Topiramate
Active Ingredient: Topiramate 200mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Apo-Topiramate
Active Ingredient: Topiramate 25mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Apo-Topiramate
Active Ingredient: Topiramate 50mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Panadol Sinus Relief PE
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia
Product: Siterone
Active Ingredient: Cyproterone acetate 100mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
Dated this 14th day of January 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).