Pixuvri

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pixantrone dimaleate

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

Overview

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 31/08/2018

Authorisation details

Product details
Name
Pixuvri
Agency product number
EMEA/H/C/002055
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
L01DB11
Additional 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 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 Limited
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
10/05/2012
Contact address
Highlands House
Basingstoke Road
Spencers Wood, Reading
Berkshire RG7 1NT
United Kingdom

Product information

23/08/2018 Pixuvri - EMEA/H/C/002055 - PSUSA/9261/201711

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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