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: CAPD/DPCA 17 ANDY Disc
Active Ingredients: Calcium chloride dihydrate 0.1838g/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 Australia Pty Limited
Manufacturers: Fresenius Medical Care Deutschland GmbH., St Wendel, Saarland, Germany
Fresenius Medical Care Espana SA, La Roca del Valles, Barcelona, Spain
Product: CAPD/DPCA 17 Sleep Safe
Active Ingredients: Calcium chloride dihydrate 0.1838g/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 Australia Pty Limited
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 18 ANDY Disc
Active Ingredients: Calcium chloride dihydrate 0.1838g/L
Glucose monohydrate 46.75g/L equivalent to glucose anhydrous 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 Australia Pty Limited
Manufacturers: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Fresenius Medical Care Espana SA, La Roca del Valles, Barcelona, Spain
Product: CAPD/DPCA 18 Sleep Safe
Active Ingredients: Calcium chloride dihydrate 0.1838g/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 Australia Pty Limited
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 19 ANDY Disc
Active Ingredients: Calcium chloride dihydrate 0.1838g/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 Australia Pty Limited
Manufacturers: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Fresenius Medical Care Espana SA, La Roca del Valles, Barcelona, Spain
Product: CAPD/DPCA 19 Sleep Safe
Active Ingredients: Calcium chloride dihydrate 0.1838g/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 Australia Pty Limited
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: Ferrosig
Active Ingredient: Iron polymaltose 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Zuellig Pharma Limited
Manufacturer: Sigma Pharmaceuticals Pty Limited, Clayton, Victoria, Australia
Dated this 22nd day of July 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).