Alofisel

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Withdrawn

This medicine's authorisation has been withdrawn

darvadstrocel
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Alofisel has been withdrawn at the request of the marketing-authorisation holder.

Alofisel : EPAR - Summary for the public

Reference Number: EMA/1380/2018

English (EN) (164.68 KB - PDF)

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български (BG) (229.17 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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español (ES) (162.17 KB - PDF)

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čeština (CS) (208.78 KB - PDF)

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dansk (DA) (158.61 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Deutsch (DE) (167.33 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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eesti keel (ET) (153.27 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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ελληνικά (EL) (234.43 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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français (FR) (165.99 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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hrvatski (HR) (195.46 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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italiano (IT) (156.75 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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latviešu valoda (LV) (203.09 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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lietuvių kalba (LT) (197.83 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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magyar (HU) (190.24 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Malti (MT) (206.96 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Nederlands (NL) (163.83 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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polski (PL) (210.32 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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português (PT) (161.5 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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română (RO) (201.52 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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slovenčina (SK) (196.4 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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slovenščina (SL) (187.62 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Suomi (FI) (154.29 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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svenska (SV) (158.01 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Alofisel : EPAR - Risk-management-plan summary

English (EN) (272.07 KB - PDF)

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Product information

Alofisel : EPAR - Product information

English (EN) (932.56 KB - PDF)

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български (BG) (1.22 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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español (ES) (1.13 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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čeština (CS) (1.25 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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dansk (DA) (1.06 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Deutsch (DE) (1.15 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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eesti keel (ET) (986.52 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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ελληνικά (EL) (1.24 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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français (FR) (1.19 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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hrvatski (HR) (1.12 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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íslenska (IS) (926.44 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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italiano (IT) (1.01 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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latviešu valoda (LV) (1.25 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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lietuvių kalba (LT) (1.26 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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magyar (HU) (1.24 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Malti (MT) (1.36 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Nederlands (NL) (1.19 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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norsk (NO) (922.99 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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polski (PL) (1.29 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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português (PT) (1.1 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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română (RO) (1.28 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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slovenčina (SK) (1.22 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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slovenščina (SL) (1.2 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Suomi (FI) (1.02 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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svenska (SV) (1.06 MB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Latest procedure affecting product information: II/0044/G
14/09/2023
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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).

Alofisel : EPAR - All Authorised presentations

English (EN) (87.98 KB - PDF)

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български (BG) (103.43 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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español (ES) (89.2 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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čeština (CS) (108.66 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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dansk (DA) (91.14 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Deutsch (DE) (85.87 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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eesti keel (ET) (87.35 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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ελληνικά (EL) (112.39 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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français (FR) (89.09 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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hrvatski (HR) (121.92 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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íslenska (IS) (86.15 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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italiano (IT) (88.69 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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latviešu valoda (LV) (108.09 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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lietuvių kalba (LT) (104.94 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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magyar (HU) (104.65 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Malti (MT) (111.89 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Nederlands (NL) (91.7 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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norsk (NO) (91.26 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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polski (PL) (112.44 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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português (PT) (86.52 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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română (RO) (107.03 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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slovenčina (SK) (107.9 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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slovenščina (SL) (99.11 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Suomi (FI) (89.58 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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svenska (SV) (88.67 KB - PDF)

First published: 04/04/2018Last updated: 21/01/2025
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Product details

Name of medicine
Alofisel
Active substance
darvadstrocel
International non-proprietary name (INN) or common name
darvadstrocel
Therapeutic area (MeSH)
Rectal Fistula
Anatomical therapeutic chemical (ATC) code
L04

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.

Authorisation details

EMA product number
EMEA/H/C/004258

Advanced therapy

This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Marketing authorisation holder
Takeda Pharma A/S

Delta Park 45
2665 Vallensbaek Strand
Denmark

Opinion adopted
14/12/2017
Marketing authorisation issued
23/03/2018
Withdrawal of marketing authorisation
13/12/2024
Revision
11

Assessment history

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

English (EN) (894.69 KB - PDF)

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Alofisel : Orphan maintenance assessment report (initial authorisation)

Reference Number: EMA/92608/2018

English (EN) (563.62 KB - PDF)

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Alofisel : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/64055/2018

English (EN) (4.69 MB - PDF)

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CHMP summary of positive opinion for Alofisel

AdoptedReference Number: EMA/CHMP/815767/2017

English (EN) (121.12 KB - PDF)

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Further information on Alofisel

Public statement on Alofisel : Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/586714/2024

English (EN) (157.82 KB - PDF)

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