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: AS-Docetaxel
Active Ingredient: Docetaxel 40mg/mL
Dosage Form: Concentrate for injection with diluent
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Docetaxel-PF
Active Ingredient: Docetaxel 40mg/mL
Dosage Form: Concentrate for injection with diluent
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: GN-Docetaxel
Active Ingredient: Docetaxel 40mg/mL
Dosage Form: Concentrate for injection with diluent
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Physioneal 40 Glucose 1.36% w/v/13.6 mg/mL CLEAR-FLEX
Active Ingredients: Calcium chloride dihydrate 0.184g/L
Glucose monohydrate 15g/L equivalent to anhydrous glucose 13.6g/L
Magnesium chloride hexahydrate 0.051g/L
Sodium bicarbonate 2.1g/L
Sodium chloride 5.38g/L
Sodium lactate 1.68g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare SA (Ireland), County Mayo, Ireland
Product: Physioneal 40 Glucose 2.27% w/v/22.7mg/mL CLEAR-FLEX
Active Ingredients: Calcium chloride dihydrate 0.184g/L
Glucose monohydrate 25g/L equivalent to anhydrous glucose 22.7g/L
Magnesium chloride hexahydrate 0.051g/L
Sodium bicarbonate 2.1g/L
Sodium chloride 5.38g/L
Sodium lactate 1.68g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare SA (Ireland), County Mayo, Ireland
Product: Physioneal 40 Glucose 3.86% w/v/38.6 mg/mL CLEAR-FLEX
Active Ingredients: Calcium chloride dihydrate 0.184g/L
Glucose monohydrate 42.5g/L equivalent to anhydrous glucose 38.6g/L
Magnesium chloride hexahydrate 0.051g/L
Sodium bicarbonate 2.1g/L
Sodium chloride 5.38g/L
Sodium lactate 1.68g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare SA (Ireland), County Mayo, Ireland
Dated this 31st day of October 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).