Fexeric

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Lapsed

This medicine's authorisation has lapsed

ferric citrate coordination complex
MedicineHumanLapsed
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 13 January 2020, the marketing authorisation of Fexeric (ferric citrate coordination complex) ceases to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Keryx Biopharma UK Ltd., had not marketed Fexeric in the EU since its initial marketing authorisation. 

In accordance with the provisions of the sunset clause, the marketing authorisation of the medicinal product lapsed as the product had not been placed on the market in any of the EU Member States within three years of its initial authorisation and during the two extensions which were granted by the European Commission at the end of the three-year period. 

Akebia Europe Limited confirmed that the product had not been marketed due to delays in identifying a commercial partner for the EU market. Fexeric was granted marketing authorisation in the EU on 23 September 2015 for the treatment of hyperphosphataemia in patients with chronic kidney disease. The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Fexeric will be updated to indicate that the marketing authorisation is no longer valid.

Fexeric : EPAR - Summary for the public

Reference Number: EMA/510659/2015

English (EN) (252.54 KB - PDF)

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български (BG) (314.37 KB - PDF)

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español (ES) (250.12 KB - PDF)

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čeština (CS) (302.38 KB - PDF)

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dansk (DA) (248.78 KB - PDF)

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Deutsch (DE) (252.04 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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eesti keel (ET) (245.44 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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ελληνικά (EL) (319.23 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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français (FR) (251.51 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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hrvatski (HR) (272.5 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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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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lietuvių kalba (LT) (276.98 KB - PDF)

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magyar (HU) (293.07 KB - PDF)

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Malti (MT) (301.08 KB - PDF)

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Nederlands (NL) (249.38 KB - PDF)

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polski (PL) (298.3 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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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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slovenščina (SL) (290.33 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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Suomi (FI) (248.57 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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svenska (SV) (246.33 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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Fexeric : EPAR - Risk-management-plan summary

Reference Number: EMA/576868/2015

English (EN) (259.25 KB - PDF)

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Product information

Fexeric : EPAR - Product Information

English (EN) (463.01 KB - PDF)

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български (BG) (937.09 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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español (ES) (462.93 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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čeština (CS) (787.3 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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dansk (DA) (465.89 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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Deutsch (DE) (490.13 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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eesti keel (ET) (468.75 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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ελληνικά (EL) (972.13 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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français (FR) (483.29 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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hrvatski (HR) (572.88 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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íslenska (IS) (471.06 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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italiano (IT) (476.59 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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latviešu valoda (LV) (785.64 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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lietuvių kalba (LT) (584.34 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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magyar (HU) (776.26 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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Malti (MT) (802.5 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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Nederlands (NL) (485.05 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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norsk (NO) (480.48 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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polski (PL) (793.89 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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português (PT) (461.27 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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română (RO) (588.89 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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slovenčina (SK) (770.04 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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slovenščina (SL) (728.68 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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Suomi (FI) (459.1 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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svenska (SV) (466.98 KB - PDF)

First published: 02/10/2015Last updated: 09/10/2019
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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)

First published: 02/10/2015Last updated: 02/10/2015
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español (ES) (180.58 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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čeština (CS) (201.02 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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dansk (DA) (180.26 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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Deutsch (DE) (180.23 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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eesti keel (ET) (180.39 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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ελληνικά (EL) (211.9 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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français (FR) (180.33 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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hrvatski (HR) (193.25 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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íslenska (IS) (181.64 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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italiano (IT) (180.4 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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latviešu valoda (LV) (205.72 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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lietuvių kalba (LT) (196.89 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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magyar (HU) (200.44 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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Malti (MT) (201.34 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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Nederlands (NL) (180.21 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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norsk (NO) (181.79 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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polski (PL) (195.46 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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português (PT) (180.35 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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română (RO) (195.44 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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slovenčina (SK) (201.5 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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slovenščina (SL) (193.66 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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Suomi (FI) (180.12 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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svenska (SV) (180.33 KB - PDF)

First published: 02/10/2015Last updated: 02/10/2015
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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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