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: Apo-Sildenafil
Active Ingredient: Sildenafil citrate 28.1mg equivalent to sildenafil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Sildenafil
Active Ingredient: Sildenafil citrate 35.12mg equivalent to sildenafil 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Sildenafil
Active Ingredient: Sildenafil citrate 70.24mg equivalent to sildenafil 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Sildenafil
Active Ingredient: Sildenafil citrate 140.48mg equivalent to sildenafil 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Chlorofluor Mouthrinse with Fluoride
Active Ingredients: Chlorhexidine gluconate 1.03mg/mL
Sodium fluoride 33µg/mL equivalent to fluoride 15µg/mL
Dosage Form: Mouthwash
New Zealand Sponsor: Oraltec (NZ) Limited
Manufacturer: Ultra Mix (Aust) Pty Limited, West Footscray, Australia
Product: Dortimopt
Active Ingredients: Dorzolamide hydrochloride 22.26mg/mL equivalent to dorzolamide 20mg/mL
Timolol maleate 6.83mg/mL equivalent to timolol 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Famar SA, Athens, Greece
Product: Easyvision Peroxide Solution
Active Ingredient: Hydrogen peroxide 3.5%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Pharmaceutical Marketing New Zealand Limited
Manufacturer: Sauflon Pharmaceuticals Limited, Kent, United Kingdom
Product: Parapaed Under 6
Active Ingredient: Paracetamol 2.4%w/w
Dosage Form: Oral suspension
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Co. Tipperary, Ireland
Product: Ursosan
Active Ingredient: Ursodeoxycholic acid 250mg
Dosage Form: Capsule
New Zealand Sponsor: ABM Pharma Limited
Manufacturer: PRO.MED.CS Praha a.s., Prague, Czech Republic
Dated this 13th day of October 2011.
DR MARK JACOBS, Acting 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).