- Application under evaluation
- CHMP opinion
- European Commission decision
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
English (EN) (252.54 KB - PDF)
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español (ES) (250.12 KB - PDF)
čeština (CS) (302.38 KB - PDF)
dansk (DA) (248.78 KB - PDF)
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eesti keel (ET) (245.44 KB - PDF)
ελληνικά (EL) (319.23 KB - PDF)
français (FR) (251.51 KB - PDF)
hrvatski (HR) (272.5 KB - PDF)
italiano (IT) (249.08 KB - PDF)
latviešu valoda (LV) (286.47 KB - PDF)
lietuvių kalba (LT) (276.98 KB - PDF)
magyar (HU) (293.07 KB - PDF)
Malti (MT) (301.08 KB - PDF)
Nederlands (NL) (249.38 KB - PDF)
polski (PL) (298.3 KB - PDF)
português (PT) (249.69 KB - PDF)
română (RO) (273.96 KB - PDF)
slovenčina (SK) (300.34 KB - PDF)
slovenščina (SL) (290.33 KB - PDF)
Suomi (FI) (248.57 KB - PDF)
svenska (SV) (246.33 KB - PDF)
Fexeric : EPAR - Risk-management-plan summary
English (EN) (259.25 KB - PDF)
Product information
Fexeric : EPAR - Product Information
English (EN) (463.01 KB - PDF)
български (BG) (937.09 KB - PDF)
español (ES) (462.93 KB - PDF)
čeština (CS) (787.3 KB - PDF)
dansk (DA) (465.89 KB - PDF)
Deutsch (DE) (490.13 KB - PDF)
eesti keel (ET) (468.75 KB - PDF)
ελληνικά (EL) (972.13 KB - PDF)
français (FR) (483.29 KB - PDF)
hrvatski (HR) (572.88 KB - PDF)
íslenska (IS) (471.06 KB - PDF)
italiano (IT) (476.59 KB - PDF)
latviešu valoda (LV) (785.64 KB - PDF)
lietuvių kalba (LT) (584.34 KB - PDF)
magyar (HU) (776.26 KB - PDF)
Malti (MT) (802.5 KB - PDF)
Nederlands (NL) (485.05 KB - PDF)
norsk (NO) (480.48 KB - PDF)
polski (PL) (793.89 KB - PDF)
português (PT) (461.27 KB - PDF)
română (RO) (588.89 KB - PDF)
slovenčina (SK) (770.04 KB - PDF)
slovenščina (SL) (728.68 KB - PDF)
Suomi (FI) (459.1 KB - PDF)
svenska (SV) (466.98 KB - PDF)
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)
български (BG) (210.72 KB - PDF)
español (ES) (180.58 KB - PDF)
čeština (CS) (201.02 KB - PDF)
dansk (DA) (180.26 KB - PDF)
Deutsch (DE) (180.23 KB - PDF)
eesti keel (ET) (180.39 KB - PDF)
ελληνικά (EL) (211.9 KB - PDF)
français (FR) (180.33 KB - PDF)
hrvatski (HR) (193.25 KB - PDF)
íslenska (IS) (181.64 KB - PDF)
italiano (IT) (180.4 KB - PDF)
latviešu valoda (LV) (205.72 KB - PDF)
lietuvių kalba (LT) (196.89 KB - PDF)
magyar (HU) (200.44 KB - PDF)
Malti (MT) (201.34 KB - PDF)
Nederlands (NL) (180.21 KB - PDF)
norsk (NO) (181.79 KB - PDF)
polski (PL) (195.46 KB - PDF)
português (PT) (180.35 KB - PDF)
română (RO) (195.44 KB - PDF)
slovenčina (SK) (201.5 KB - PDF)
slovenščina (SL) (193.66 KB - PDF)
Suomi (FI) (180.12 KB - PDF)
svenska (SV) (180.33 KB - PDF)
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)
Fexeric : EPAR - Public assessment report
English (EN) (3.31 MB - PDF)
CHMP summary of positive opinion for Fexeric
English (EN) (292.85 KB - PDF)
News on Fexeric
More information on Fexeric
Public statement on Fexeric: Cessation of validity of the marketing authorisation in the European Union
English (EN) (120.28 KB - PDF)