✨ 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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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2015, No 83





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
23 July 2015
Medicines, Distribution, Omalizumab, Xolair, Novartis
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution, Dianeal, Peritoneal Dialysis Solution, Baxter Healthcare