EU/3/14/1424:

Humanised Fc engineered monoclonal antibody against CD19, active ingredient tafasitamab

Overview

This medicine is now known as tafasitamab.

On 15 January 2015, orphan designation (EU/3/14/1424) was granted by the European Commission to MorphoSys AG, Germany, for humanised Fc engineered monoclonal antibody against CD19 for the treatment of diffuse large B-cell lymphoma.

The sponsorship was transferred to Incyte Biosciences Distribution B.V., Netherlands, in July 2020.

Key facts

Active substance
Humanised Fc engineered monoclonal antibody against CD19, active ingredient tafasitamab
Intented use
Treatment of diffuse large B-cell lymphoma
Date of designation
15/01/2015
Orphan designation status
Positive
EU designation number
EU/3/14/1424

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

Incyte Biosciences Distribution B.V.
Paasheuvelweg 25
1105 BP Amsterdam 
Noord-Holland
Netherlands
E-mail: RA@incyte.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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