EU/3/09/667

Table of contents

About

This medicine is now known as darvadstrocel.

On 8 October 2009, orphan designation (EU/3/09/667) was granted by the European Commission to Cellerix S.A., Spain, for expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue for the treatment of anal fistula.

In February 2013, Cellerix S.A. changed name to TiGenix S.A.U.

Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue has been authorised in the EU as Alofisel since 23 March 2018.

The sponsorship was transferred to Takeda Pharma A/S - Denmark in May 2018.

Key facts

Active substance
Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (darvadstrocel)
Disease / condition
Treatment of anal fistula
Date of decision
08/10/2009
Outcome
Positive
Orphan decision number
EU/3/09/667

Sponsor's contact details

Takeda Pharma A/S
Dybendal Alle 10
Taastrup
2630 Denmark
Tel. +45 46 77 1036

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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