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.

Fexeric : EPAR - Summary for the public

Reference Number: EMA/510659/2015

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Deutsch (DE) (252.04 KB - PDF)

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eesti keel (ET) (245.44 KB - PDF)

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ελληνικά (EL) (319.23 KB - PDF)

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français (FR) (251.51 KB - PDF)

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italiano (IT) (249.08 KB - PDF)

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latviešu valoda (LV) (286.47 KB - PDF)

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Nederlands (NL) (249.38 KB - PDF)

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polski (PL) (298.3 KB - PDF)

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português (PT) (249.69 KB - PDF)

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română (RO) (273.96 KB - PDF)

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slovenčina (SK) (300.34 KB - PDF)

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Suomi (FI) (248.57 KB - PDF)

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svenska (SV) (246.33 KB - PDF)

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Fexeric : EPAR - Risk-management-plan summary

Reference Number: EMA/576868/2015

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Product information

Fexeric : EPAR - Product Information

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čeština (CS) (787.3 KB - PDF)

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dansk (DA) (465.89 KB - PDF)

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Deutsch (DE) (490.13 KB - PDF)

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eesti keel (ET) (468.75 KB - PDF)

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ελληνικά (EL) (972.13 KB - PDF)

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français (FR) (483.29 KB - PDF)

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italiano (IT) (476.59 KB - PDF)

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latviešu valoda (LV) (785.64 KB - PDF)

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lietuvių kalba (LT) (584.34 KB - PDF)

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magyar (HU) (776.26 KB - PDF)

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Malti (MT) (802.5 KB - PDF)

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Nederlands (NL) (485.05 KB - PDF)

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polski (PL) (793.89 KB - PDF)

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português (PT) (461.27 KB - PDF)

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română (RO) (588.89 KB - PDF)

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slovenščina (SL) (728.68 KB - PDF)

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Suomi (FI) (459.1 KB - PDF)

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svenska (SV) (466.98 KB - PDF)

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Latest procedure affecting product information: T/0015

09/09/2019

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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).

Fexeric : EPAR - All Authorised presentations

English (EN) (178.18 KB - PDF)

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български (BG) (210.72 KB - PDF)

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español (ES) (180.58 KB - PDF)

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čeština (CS) (201.02 KB - PDF)

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dansk (DA) (180.26 KB - PDF)

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Deutsch (DE) (180.23 KB - PDF)

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eesti keel (ET) (180.39 KB - PDF)

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ελληνικά (EL) (211.9 KB - PDF)

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français (FR) (180.33 KB - PDF)

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hrvatski (HR) (193.25 KB - PDF)

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íslenska (IS) (181.64 KB - PDF)

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italiano (IT) (180.4 KB - PDF)

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latviešu valoda (LV) (205.72 KB - PDF)

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lietuvių kalba (LT) (196.89 KB - PDF)

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magyar (HU) (200.44 KB - PDF)

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Malti (MT) (201.34 KB - PDF)

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Nederlands (NL) (180.21 KB - PDF)

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norsk (NO) (181.79 KB - PDF)

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polski (PL) (195.46 KB - PDF)

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português (PT) (180.35 KB - PDF)

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română (RO) (195.44 KB - PDF)

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slovenčina (SK) (201.5 KB - PDF)

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slovenščina (SL) (193.66 KB - PDF)

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Suomi (FI) (180.12 KB - PDF)

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svenska (SV) (180.33 KB - PDF)

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Product details

Name of medicine
Fexeric
Active substance
ferric citrate coordination complex
International non-proprietary name (INN) or common name
ferric citrate coordination complex
Therapeutic area (MeSH)
  • Hyperphosphatemia
  • Renal Dialysis
Anatomical therapeutic chemical (ATC) code
V03AE

Therapeutic indication

Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD).

Authorisation details

EMA product number
EMEA/H/C/003776
Marketing authorisation holder
Akebia Europe Limited

c/o Matheson
70 Sir John Rogerson’s Quay
Dublin 2
Ireland

Marketing authorisation issued
23/09/2015
Lapse of marketing authorisation
13/01/2020
Revision
2

Assessment history

Fexeric : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (320.19 KB - PDF)

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Fexeric : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/535898/2015

English (EN) (3.31 MB - PDF)

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CHMP summary of positive opinion for Fexeric

AdoptedReference Number: EMA/CHMP/453873/2015

English (EN) (292.85 KB - PDF)

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More information on Fexeric

Public statement on Fexeric: Cessation of validity of the marketing authorisation in the European Union

Reference Number: EMA/4863/2020

English (EN) (120.28 KB - PDF)

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