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: Avelox
Active Ingredient(s): Moxifloxacin hydrochloride 436.8mg equivalent to 400mg moxifloxacin
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited Health Care Division
Manufacturer(s): Bayer AG, Leverkusen, Germany
Product: Crystacide
Active Ingredient(s): Hydrogen peroxide 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Bioglan AB, Malmo, Sweden
Product: Disodium Pamidronate Concentrated Injection
Active Ingredient(s): Pamidronic acid 2.53mg/mL equivalent to 3 mg/ml pamidronate disodium
Dosage Form: Concentrate for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Disodium Pamidronate Concentrated Injection
Active Ingredient(s): Pamidronic acid 5.05mg/mL equivalent to 6 mg/ml pamidronate disodium
Dosage Form: Concentrate for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Disodium Pamidronate Concentrated Injection
Active Ingredient(s): Pamidronic acid 7.58mg/mL equivalent to 9 mg/ml pamidronate disodium
Dosage Form: Concentrate for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Zometa
Active Ingredient(s): Zoledronic acid anhydrous 4mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Dated this 14th day of February 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).