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Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Publication Date
9 Sep 2021

Tags

Medicines Act Renewal of provisional consent to the distribution of medicines Health

Notice Number

2021-go3870
Title
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File Type and Size
PDF (36 KB)

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: Dianeal 1mmol/L Calcium with 1.5% w/v glucose monohydrate
Active Ingredients: 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
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Sydney, Australia
Note: This renewed consent is valid for two years from 12 September 2021.
   
Product: Dianeal 1mmol/L Calcium with 2.5% w/v glucose monohydrate
Active Ingredients: 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
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Sydney, Australia
Note: This renewed consent is valid for two years from 12 September 2021.
   
Product: Dianeal 1mmol/L Calcium with 4.25% w/v glucose monohydrate
Active Ingredients: 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
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Sydney, Australia
Note: This renewed consent is valid for two years from 12 September 2021.
   
Product: Dianeal PD4 with 0.55% w/v glucose monohydrate
Active Ingredients: 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
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Sydney, Australia
Note: This renewed consent is valid for two years from 12 September 2021.


Dated this 6th day of September 2021.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).