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EMA Product

Lunsumio

Product approved by European Medicines Agency (EU)

Basic Information

Lunsumio

Regulatory Information

EMEA/H/C/005680

Authorised

June 3, 2022

April 22, 2022

6

October 22, 2024

Company Information

Germany

Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen

Roche Registration GmbH

Drug Classification

Orphan MedicineConditional ApprovalAdditional Monitoring

Active Ingredients

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Overview Summary

Lunsumio is a cancer medicine used to treat adults with follicular lymphoma that does not respond to (refractory) or has come back (relapsed) after at least two previous treatments. Follicular lymphoma is rare, and Lunsumio was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 November 2021. Further information on the orphan designation can be found here: [ema.europa.eu/medicines/human/orphan-designations/EU3212517](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2517) Lunsumio contains the active substance mosunetuzumab.

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