pixantrone dimaleate

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Pixuvri. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pixuvri.

This EPAR was last updated on 02/09/2019

Authorisation details

Product details
Agency product number
Active substance
pixantrone dimaleate
International non-proprietary name (INN) or common name
pixantrone dimaleate
Therapeutic area (MeSH)
Lymphoma, Non-Hodgkin
Anatomical therapeutic chemical (ATC) code
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.

Publication details
Marketing-authorisation holder
CTI Life Sciences Deutschland GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Universitätsstraβe 71
Köln, 50931

Product information

06/06/2019 Pixuvri - EMEA/H/C/002055 - R/0046


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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth-line or greater chemotherapy in patients who are refractory to last therapy.

Assessment history

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