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: Allersoothe
Active Ingredient: Promethazine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Matrix Laboratories Limited, Sinnar, Nashik, Maharashta, India
Product: Allersoothe
Active Ingredient: Promethazine hydrochloride 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Matrix Laboratories Limited, Sinnar, Nashik, Maharashta, India
Product: Apo-Terazosin
Active Ingredient: Terazosin hydrochloride dihydrate 2.38mg equivalent to terazosin 2mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Terazosin
Active Ingredient: Terazosin hydrochloride dihydrate 5.95mg equivalent to terazosin 5mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Bio-fit Multi Purpose Solution
Active Ingredients: Baquacil 0.0001%w/v
Poloxamer 0.05%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Advanced Medical Optics Australia Pty Limited
Manufacturer: AMO (Hangzhou) Co Limited, Hangzhou, Zhejiang, China
Product: Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 291.08mg equivalent to ciprofloxacin base 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka – Daund, District – Pune, Maharashtra State, India
Product: Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 582.16mg equivalent to ciprofloxacin base 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka – Daund, District – Pune, Maharashtra State, India
Product: Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 873.24mg equivalent to ciprofloxacin base 750mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka – Daund, District – Pune, Maharashtra State, India
Product: Invirase
Active Ingredient: Saquinavir mesilate 571.5mg equivalent to saquinavir 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Farma SA, Poligono Ind. Leganes, Leganes (Madrid), Spain
Product: Timolux
Active Ingredient: Timolol maleate 3.42mg/mL equivalent to timolol base 2.5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Tubilux Pharma SpA, Pomezia, Rome, Italy
Product: Timolux
Active Ingredient: Timolol maleate 6.83mg/mL equivalent to timolol base 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Tubilux Pharma SpA, Pomezia, Rome, Italy
Product: Zepilen
Active Ingredient: Cefazolin sodium 1.08g equivalent to cefazolin 1g
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Medochemie Limited, Agios Athanasios Industrial Estate, Limassol, Cyprus
Product: Zepilen
Active Ingredient: Cefazolin sodium 540mg equivalent to cefazolin 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Medochemie Limited, Agios Athanasios Industrial Estate, Limassol, Cyprus
Dated this 7th day of September 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).