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-Betaxolol
Active Ingredient(s): Betaxolol hydrochloride 5.6mg/mL equivalent to 0.5% betaxolol base
Dosage Form: Eye drops, solution
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Novex Pharma Inc, Richmond Hill, Ontario, Canada
Product: Canesten Bifonazole 1% Anti Dandruff Shampoo
Active Ingredient(s): Bifonazole 1%w/w
Dosage Form: Shampoo
New Zealand Sponsor: Bayer New Zealand Limited Health Care Division
Manufacturer(s): Pax Australia Pty Limited, Ingleburn, New South Wales, Australia
Product: CAPD/DPCA 10 ANDY disc
Active Ingredient(s): Calcium chloride (dihydrate) 0.147g/L
Glucose monohydrate 16.5g/L equivalent to glucose anhydrous 15g/L
Magnesium chloride (hexahydrate) 0.1017g/L
Sodium chloride 5.786g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer(s): Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Fresenius Medical Care Espana SA, La Roca del Valles, Barcelona, Spain
Product: CAPD/DPCA 11 ANDY disc
Active Ingredient(s): Calcium chloride (dihydrate) 0.147g/L
Glucose monohydrate 46.75g/L equivalent to glucose anydrous 42.5g/L
Magnesium chloride (hexahydrate) 0.1017g/L
Sodium chloride 5.786g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer(s): Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Fresenius Medical Care Espana SA, La Roca del Valles, Barcelona, Spain
Product: CAPD/DPCA 12 ANDY disc
Active Ingredient(s): Calcium chloride (dihydrate) 0.147g/L
Glucose monohydrate 25g/L equivalent to glucose anydrous 22.7g/L
Magnesium chloride (hexahydrate) 0.1017g/L
Sodium chloride 5.786g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer(s): Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Fresenius Medical Care Espana SA, La Roca del Valles, Barcelona, Spain
Product: CAPD/DPCA 2 ANDY disc
Active Ingredient(s): Calcium chloride (dihydrate) 0.2573g/L
Glucose monohydrate 16.5g/L equivalent to glucose anydrous 15g/L
Magnesium chloride (hexahydrate) 0.1017g/L
Sodium chloride 5.786g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer(s): Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Fresenius Medical Care Espana SA, La Roca del Valles, Barcelona, Spain
Product: CAPD/DPCA 3 ANDY disc
Active Ingredient(s): Calcium chloride (dihydrate) 0.2573g/L
Glucose monohydrate 46.75g/L equivalent to glucose anydrous 42.5g/L
Magnesium chloride (hexahydrate) 0.1017g/L
Sodium chloride 5.786g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer(s): Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Fresenius Medical Care Espana SA, La Roca del Valles, Barcelona, Spain
Product: CAPD/DPCA 4 ANDY disc
Active Ingredient(s): Calcium chloride (dihydrate) 0.2573g/L
Glucose monohydrate 25g/L equivalent to glucose anhydrous 22.7g/L
Magnesium chloride (hexahydrate) 0.1017g/L
Sodium chloride 5.786g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer(s): Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Fresenius Medical Care Espana SA, La Roca del Valles, Barcelona, Spain
Product: Voltaren Rapid 25
Active Ingredient(s): Diclofenac potassium 25mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis Consumer Health Australasia Pty. Limited.
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Dated this 15th day of November 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).