Lunsumio

RSS

mosunetuzumab

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

Overview

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: https://www.ema.europa.eu/en/documents/orphan-maintenance-report/lunsumi...

Lunsumio contains the active substance mosunetuzumab.

This EPAR was last updated on 23/06/2022

Authorisation details

Product details
Name
Lunsumio
Agency product number
EMEA/H/C/005680
Active substance
mosunetuzumab
International non-proprietary name (INN) or common name
mosunetuzumab
Therapeutic area (MeSH)
Lymphoma, Follicular
Anatomical therapeutic chemical (ATC) code
L01XC
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
Roche Registration GmbH
Date of issue of marketing authorisation valid throughout the European Union
03/06/2022
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

Lunsumio - EMEA/H/C/005680 -

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Monoclonal antibodies

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. 

Assessment history

Related content

How useful was this page?

Add your rating
Average
2 ratings