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-Salvent Sterules
Active Ingredient: Salbutamol sulphate 1.2mg/mL equivalent to Salbutamol 1mg/mL
Dosage Form: Solution for inhalation
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Novex Pharma Inc, Richmond Hill, Ontario, Canada
Product: Apo-Salvent Sterules
Active Ingredient: Salbutamol sulphate 2.4mg/mL equivalent to Salbutamol 2mg/mL
Dosage Form: Solution for inhalation
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Novex Pharma Inc, Richmond Hill, Ontario, Canada
Product: CAPD/DPCA 2 Sleep Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.2573g/L
Glucose monohydrate 16.5g/L equivalent to 15g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 2 Stay Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.2573g/L
Glucose monohydrate 16.5g/L equivalent to glucose anhydrous 15g/L
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 3 Sleep Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.2573g/L
Glucose monohydrate 46.75g/L equivalent to 42.5g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 3 Stay Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.2573g/L
Glucose monohydrate 46.75g/L equivalent to 42.5g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 4 Sleep Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.2573g/L
Glucose monohydrate 25g/L equivalent to 22.73g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 4 Stay Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.2573g/L
Glucose monohydrate 25g/L equivalent to 22.73g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 10 Sleep Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.147g/L
Glucose monohydrate 16.5g/L equivalent to 15g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 10 Stay Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.147g/L
Glucose monohydrate 16.5g/L equivalnet to 15g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 11 Sleep Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.147g/L
Glucose monohydrate 46.75g/L equivalent to 42.5g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 11 Stay Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.147g/L
Glucose monohydrate 46.75g/L equivalent to 42.5g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 12 Sleep Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.147g/L
Glucose monohydrate 25g/L equivalent to 22.73g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 12 Stay Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.147g/L
Glucose monohydrate 25g/L equivalent to 22.73g/L glcose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 17 Sleep Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.1838g/L
Glucose monohydrate 16.5g/L equivalent to 15g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 17 Stay Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.1838g/L
Glucose monohydrate 16.5g/L equivalent to 15g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 18 Sleep Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.1838g/L
Glucose monohydrate 46.75g/L
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 18 Stay Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.1838g/L
Glucose monohydrate 46.75g/L
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: CAPD/DPCA 19 Sleep Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.1838g/L
Glucose monohydrate 25g/L equivalent to 22.73g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbHSt Wendel, Saarland, Germany
Product: CAPD/DPCA 19 Stay Safe Balance
Active Ingredients: Calcium chloride dihydrate 0.1838g/L
Glucose monohydrate 25g/L equivalentt to 22.73g/L glucose anhydrous
Magnesium chloride hexahydrate 0.1017g/L
Sodium chloride 5.64g/L
Sodium lactate 3.925g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product: Copegus
Active Ingredient: Ribavirin 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Patheon Inc, Mississauga, Ontario, Canada
Product: Crinone 8%
Active Ingredient: Progesterone 8%w/w equivalent to 90mg progesterone/1.125g dose
Dosage Form: Vaginal gel
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Fleet Laboratories Limited, Watford, Hertfordshire, United Kingdom
Product: Lemsip Max Day & Night
Daytime component:
Active Ingredients: Dextromethorphan hydrobromide 10mg
Paracetamol 300mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Liquid filled capsule
Night-time component:
Active Ingredients: Chlorpheniramine maleate 2mg
Paracetamol 300mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: R P Scherer Holdings Pty Limited, Braeside, Victoria, Australia
Product: X-Opaque HD
Active Ingredient: Barium sulphate 966mg/g
Dosage Form: Oral suspension
New Zealand Sponsor: Siemens (NZ) Limited
Manufacturer: Hellay Laboratories Pty Limited, Dandenong, Victoria, Australia
Dated this 9th day of October 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).