β¨ Medicine Distribution Consents
NEW ZEALAND GAZETTE, No. 83 β 30 JULY 2015
Product:
Xolair
Active Ingredient:
Omalizumab 150mg
Dosage Form:
Injection with diluent
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturers:
Genentech Inc, California, United States of America
Novartis Pharma Stein AG, Stein, Switzerland
Dated this 23rd day of July 2015.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2015-go4408
Renewal of Provisional Consent to the Distribution of Medicines
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 Peritoneal Dialysis Solution
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, New South Wales, Australia
Note: This renewed consent is valid for two years from 12 September 2015.
Product:
Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution
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, New South Wales, Australia
Note: This renewed consent is valid for two years from 12 September 2015.
Product:
Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution
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, New South Wales, Australia
Note: This renewed consent is valid for two years from 12 September 2015.
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β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare23 July 2015
Medicines, Distribution, Omalizumab, Xolair, Novartis
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Renewal of Provisional Consent to the Distribution of Medicines
π₯ Health & Social WelfareMedicines, Distribution, Dianeal, Peritoneal Dialysis Solution, Baxter Healthcare
NZ Gazette 2015, No 83