Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
sevelamer carbonate
Table of contents
Overview
Sevelamer carbonate Winthrop is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:
- adult patients on dialysis (a technique to remove unwanted substances from the blood);
- adults and children from 6 years of age with chronic (long term) kidney disease.
Sevelamer carbonate Winthrop should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease. It contains the active substance sevelamer carbonate.
Authorisation details
Product details | |
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Name |
Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
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Agency product number |
EMEA/H/C/003971
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Active substance |
sevelamer carbonate
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International non-proprietary name (INN) or common name |
sevelamer carbonate
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
V03AE02
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Publication details | |
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Marketing-authorisation holder |
Sanofi B.V.
|
Revision |
21
|
Date of issue of marketing authorisation valid throughout the European Union |
15/01/2015
|
Contact address |
Paasheuvelweg 25 |
Product information
23/05/2023 Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) - EMEA/H/C/003971 - IAIN/0034
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
All other therapeutic products
Therapeutic indication
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L.
Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.