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 10 Sleep Safe
Active Ingredient(s): Calcium chloride (dihydrate) 0.147g/L
Glucose monohydrate 16.5g/L equivalent 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
Product: CAPD/DPCA 11 Sleep Safe
Active Ingredient(s): Calcium chloride (dihydrate) 0.147g/L
Glucose monohydrate 46.75g/L equivalent 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 New Zealand
Manufacturer(s): Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 12 Sleep Safe
Active Ingredient(s): Calcium chloride (dihydrate) 0.147g/L
Glucose monohydrate 25g/L equivalent glucose anhydrous 22.73g/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
Product: CAPD/DPCA 2 Sleep Safe
Active Ingredient(s): Calcium chloride (dihydrate) 0.2573g/L
Glucose monohydrate 16.5g/L equivalent 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
Product: CAPD/DPCA 3 Sleep Safe
Active Ingredient(s): Calcium chloride (dihydrate) 0.2573g/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 New Zealand
Manufacturer(s): Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 4 Sleep Safe
Active Ingredient(s): Calcium chloride (dihydrate) 0.2573g/L
Glucose monohydrate 25g/L equivalent glucose anhydrous 22.73g/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
Product: Somatuline LA
Active Ingredient(s): Lanreotide 30mg
Dosage Form: Powder for injection
New Zealand Sponsor: New Zealand Medical & Scientific Ltd
Manufacturer(s): Pharma Biotech, Signes, France
Dated this 31st day of October 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).