Fexeric
ferric citrate coordination complex
Table of contents
Overview
This marketing authorisation for Fexeric has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.
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List item
Fexeric : EPAR - Summary for the public (PDF/252.54 KB)
First published: 02/10/2015
Last updated: 02/10/2015
EMA/510659/2015 -
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List item
Fexeric : EPAR - Risk-management-plan summary (PDF/259.25 KB)
First published: 02/10/2015
Last updated: 02/10/2015
EMA/576868/2015
Authorisation details
| Product details | |
|---|---|
| Name |
Fexeric
|
| Agency product number |
EMEA/H/C/003776
|
| Active substance |
ferric citrate coordination complex
|
| International non-proprietary name (INN) or common name |
ferric citrate coordination complex
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
V03AE
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Akebia Europe Limited
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
23/09/2015
|
| Contact address |
c/o Matheson |
Product information
09/09/2019 Fexeric - EMEA/H/C/003776 - T/0015
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
Therapeutic indication
Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD).