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 Stay Safe
Active Ingredient(s): 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 5.786g/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 18 Stay Safe
Active Ingredient(s): Calcium chloride (dihydrate) 0.1838g/L
Glucose monohydrate 46.75g/L equivalent to 42.5 g/L glucose anhydrous
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 19 Stay Safe
Active Ingredient(s): Calcium chloride (dihydrate) 0.1838g/L
Glucose monohydrate 25g/L equivalent to 22.7g/L glucose anhydrous
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: Nicotinell
Active Ingredient(s): Nicotine bitartrate dihydrate 3.072mg
Dosage Form : Lozenge
New Zealand Sponsor: Novartis Consumer Health Australasia Pty. Limited
Manufacturer(s): Sanico NV, Turnhout, Belgium
Product: Omnicare 1 Step Travel Pack (Combination Product)
Dosage Form (1): Lens Plus Purite Contact lens solution
Active Ingredient(s): Sodium chloride 0.85%w/v
Dosage Form (2): Omnicare Daily Cleaner Contact lens solution
Active Ingredient(s): Coconut diethanolamide 1%w/v
Miranol (imidazoline derivative) 1.5%w/v
Sodium tridecyl ether (3) sulphate 1.5%w/v
Dosage Form (3): Omnicare Disinfecting Solution Contact lens solution
Active Ingredient(s): Hydrogen peroxide 3.1%w/v
Dosage Form (4): Omnicare Neutralising 1 Step Tablet for contact lens solution
Active Ingredient(s): Catalase 0.1mg
Dosage Form (5): Ultrazyme Protein Remover Tablet for contact lens solution
Active Ingredient(s): Subtilisin 0.4mg
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer(s): Allergan Pharmaceuticals (Ireland) Limited, Westport, County Mayo, Eire
Product: Serviflox
Active Ingredient(s): Ciprofloxacin hydrochloride 116.6mg equivalent to 100mg ciprofloxacin
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Delta Limited, Hafnarfjordur, Iceland
Product: Serviflox
Active Ingredient(s): Ciprofloxacin hydrochloride 291.5mg equivalent to 250mg ciprofloxacin
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Delta Limited, Hafnarfjordur, Iceland
Product: Serviflox
Active Ingredient(s): Ciprofloxacin hydrochloride 583mg equivalent to 500mg ciprofloxacin
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Delta Limited, Hafnarfjordur, Iceland
Product: Serviflox
Active Ingredient(s): Ciprofloxacin hydrochloride 874.5mg equivalent to 750mg ciprofloxacin
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Delta Limited, Hafnarfjordur, Iceland
Product: Singulair
Active Ingredient(s): Montelukast sodium 4.16mg equivalent to 4mg montelukast free acid
Dosage Form: Chewable tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, Wilson Plant, North Carolina, United States of AmericaMerck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Product: Tirlor
Active Ingredient(s): Loratadine 10%w/w
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Limited, Tongi, Gazipur, Bangladesh
Product: Tri Profen
Active Ingredient(s): Ibuprofen 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: 3M Pharmaceuticals - a division of 3M New Zealand Limited
Manufacturer(s): 3M Pharmaceuticals (Australia) Pty Limited, Thornleigh, New South Wales, Australia
Product: Walco Quick Eze Lemon Flavour
Active Ingredient(s): Calcium carbonate 750mg
Magnesium carbonate 123mg
Magnesium trisilicate (hydrate) 123mg
Dosage Form: Tablet
New Zealand Sponsor: Nestle New Zealand Limited
Manufacturer(s): Nestle Australia Limited, Blacktown, New South Wales, Australia
Dated this 20th day of December 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).