This medicine is now known as tafasitamab.
The medicinal product has been authorised in the EU as Minjuvi since 26 August 2021.
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.
Humanised Fc engineered monoclonal antibody against CD19 (tafasitamab)
Treatment of diffuse large B-cell lymphoma
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Review of designation
Documents related to this orphan designation evaluation
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.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: