Lokelma
sodium zirconium cyclosilicate
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Lokelma. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Lokelma.
For practical information about using Lokelma, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Lokelma : EPAR - Summary for the public (PDF/67.53 KB)
First published: 05/04/2018
Last updated: 05/04/2018
EMA/126082/2018 -
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List item
Lokelma : EPAR - Risk-management-plan summary (PDF/76.46 KB)
First published: 07/05/2020
Authorisation details
Product details | |
---|---|
Name |
Lokelma
|
Agency product number |
EMEA/H/C/004029
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Active substance |
sodium zirconium cyclosilicate
|
International non-proprietary name (INN) or common name |
sodium zirconium cyclosilicate
|
Therapeutic area (MeSH) |
Hyperkalemia
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Anatomical therapeutic chemical (ATC) code |
V03AE10
|
Publication details | |
---|---|
Marketing-authorisation holder |
AstraZeneca AB
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Revision |
9
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Date of issue of marketing authorisation valid throughout the European Union |
22/03/2018
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Contact address |
151 85 Sodertalje |
Product information
26/04/2023 Lokelma - EMEA/H/C/004029 - IAIN/0030/G
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
Lokelma is indicated for the treatment of hyperkalaemia in adult patients.