Minjuvi

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tafasitamab

Authorised
This medicine is authorised for use in the European Union.

Overview

Minjuvi is a cancer medicine used first in combination with another medicine called lenalidomide, and then on its own, to treat adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has stopped responding to other treatments and who cannot have an autologous stem cell transplantation (a transplant where the stem cells are collected from the patients themselves). 

DLBCL is rare, and Minjuvi was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 January 2015. Further information on the orphan designation can be found here.

Minjuvi contains the active substance tafasitamab.

This EPAR was last updated on 08/09/2021

Authorisation details

Product details
Name
Minjuvi
Agency product number
EMEA/H/C/005436
Active substance
Tafasitamab
International non-proprietary name (INN) or common name
tafasitamab
Therapeutic area (MeSH)
Lymphoma, Large B-Cell, Diffuse
Anatomical therapeutic chemical (ATC) code
L01XC35
Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Incyte Biosciences Distribution B.V.
Date of issue of marketing authorisation valid throughout the European Union
26/08/2021
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
Netherlands

Product information

26/08/2021 Minjuvi - EMEA/H/C/005436 -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Minjuvi is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Assessment history

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