Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Schedule
|
Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution
Calcium chloride dihydrate 0.1455g/L
Glucose monohydrate 14.85g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dialysis solution
Baxter Healthcare Limited
Baxter Healthcare Pty Limited, Sydney, Australia
|
Note: This renewed consent is valid for two years from 12 September 2017.
|
Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution
Calcium chloride dihydrate 0.1455g/L
Glucose monohydrate 24.75g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dialysis solution
Baxter Healthcare Limited
Baxter Healthcare Pty Limited, Sydney, Australia
|
Note: This renewed consent is valid for two years from 12 September 2017.
|
Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution
Calcium chloride dihydrate 0.1455g/L
Glucose monohydrate 42.08g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dialysis solution
Baxter Healthcare Limited
Baxter Healthcare Pty Limited, Sydney, Australia
|
Note: This renewed consent is valid for two years from 12 September 2017.
|
Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Dianeal PD-4 Peritoneal Dialysis Solution
Calcium chloride dihydrate 0.181g/L
Glucose monohydrate 5.45g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dialysis solution
Baxter Healthcare Limited
Baxter Healthcare Pty Limited, Sydney, Australia
|
Note: This renewed consent is valid for two years from 12 September 2017.
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Fentanyl
Fentanyl citrate 15.71mg/L equivalent to fentanyl 10mg/L
Solution for infusion
Biomed Limited
Biomed Limited, Auckland, New Zealand
|
Note: This renewed consent is valid for two years from 23 September 2017.
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Fentanyl
Fentanyl citrate 31.42mg/L equivalent to fentanyl 20mg/L
Solution for infusion
Biomed Limited
Biomed Limited, Auckland, New Zealand
|
Note: This renewed consent is valid for two years from 23 September 2017.
Dated this 1st day of September 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).