EMA — authorised 26 August 2021
- Marketing authorisation holder: INCYTE BIOSCIENCES DISTRIBUTION B.V.
- Local brand name: Xmab5574
- Status: approved
🇪🇺 Xmab5574 in European Union
EMA authorised Xmab5574 on 26 August 2021
Marketing authorisations
EMA — authorised 26 August 2021
- Application: EMEA/H/C/005436
- Marketing authorisation holder: Incyte Biosciences Distribution B.V.
- Local brand name: Minjuvi
- 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).
- Pathway: conditional, orphan
- Status: approved
Xmab5574 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Xmab5574 approved in European Union?
Yes. EMA authorised it on 26 August 2021; EMA authorised it on 26 August 2021.
Who is the marketing authorisation holder for Xmab5574 in European Union?
INCYTE BIOSCIENCES DISTRIBUTION B.V. holds the EU marketing authorisation.