EU/3/16/1826

About

This medicine is now known as imlifidase.

On 12 January 2017, orphan designation (EU/3/16/1826) was granted by the European Commission to Hansa Medical AB, Sweden, for recombinant IgG degrading enzyme of Streptococcus pyogenes (also known as HMED-Ides) for the prevention of graft rejection following solid organ transplantation.

In February, Hansa Medical AB changed name to Hansa Biopharma AB.

Recombinant IgG degrading enzyme of Streptococcus pyogenes has been authorised in the EU as Idefirix since 25 August 2020.

Key facts

Active substance
Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase)
Medicine name
Idefirix
Disease / condition
Prevention of graft rejection following solid organ transplantation
Date of first decision
12/01/2017
Outcome
Positive
EU designation number
EU/3/16/1826

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Idefirix at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Sponsor's contact details

Hansa Biopharma AB
Scheelevägen 22
P.O. Box 785
Tel. +46 4616 5670
E-mail: info@hansamedical.com

Patients' organisations

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

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

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