EU/3/14/1424

About

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
Disease / condition
Treatment of diffuse large B-cell lymphoma
Date of first decision
15/01/2015
Outcome
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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