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: Arrow - Azithromycin
Active Ingredient: Azithromycin monohydrate 511.35mg equivalent to azithromycin 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Pharmaceuticals Inc, Mississauga, Ontario, Canada
Product: Arrow - Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 291.11mg equivalent to ciprofloxacin 250mg, as monohydrate
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Sigma Pharmaceuticals Pty Ltd, (Tablet manufacturing site), Croydon, Victoria, Australia
Sigma Pharmaceuticals Pty Ltd, Baulkham Hills, New South Wales, Australia
Product: Arrow - Ciprofloxacin
Active Ingredients: Ciprofloxacin hydrochloride 582.21mg equivalent to ciprofloxacin 500mg, as monohydrate
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Sigma Pharmaceuticals Pty Ltd, (Tablet manufacturing site), Croydon, Victoria, Australia
Sigma Pharmaceuticals Pty Ltd, Baulkham Hills, New South Wales, Australia
Product: Arrow - Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 873.32mg equivalent to ciprofloxacin 750mg, as monohydrate
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Sigma Pharmaceuticals Pty Ltd, (Tablet manufacturing site), Croydon, Victoria, Australia
Sigma Pharmaceuticals Pty Ltd, Baulkham Hills, New South Wales, Australia
Product: Clarac
Active Ingredient: Clarithromycin 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland
Product: Dispersible Aspirin
Active Ingredient: Aspirin 300mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Ltd, Manufacturing Division, Kurkumbh Village, Taluka - Daund, Pune, Maharashtra, India
Product: Hepsera
Active Ingredient: Adefovir dipivoxil 10mg
Dosage Form: Tablet
New Zealand Sponsor: Muir Hutchison Limited
Manufacturer: Patheon Inc, Mississauga, Ontario, Canada
Product: Lemoxol
Active Ingredient: Ceftazidime pentahydrate 1,160mg equivalent to ceftazidime 1,000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA, Athens-Lamia, Kryoneri, Athens, Greece
Product: Lemoxol
Active Ingredient: Ceftazidime pentahydrate 2,320mg equivalent to ceftazidime 2,000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA, Athens-Lamia, Kryoneri, Athens, Greece
Product: Paracetamol
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: BJM Distributors Limited
Manufacturer: Strides Arcolab Ltd, Indlawadi Cross, Anekal Taluk, Bangalore, India
Dated this 29th day of July 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).