On 14 July 2016, orphan designation (EU/3/16/1698) was granted by the European Commission to Immungenetics AG, Germany, for dimethyl fumarate for the treatment of bullous pemphigoid.

The sponsorship was transferred to Novalis Investments S.L. in February 2019.

Key facts

Active substance
dimethyl fumarate
Disease / condition
Treatment of bullous pemphigoid
Date of first decision
EU designation number

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Novalis Investments S.L. 
Calle Casbah Del Saler 2 56 
46012 Valencia 
Tel.: +491727326745

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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