Pixuvri
pixantrone dimaleate
Table of contents
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.
-
List item
Pixuvri : EPAR - Summary for the public (PDF/64.96 KB)
First published: 31/05/2012
Last updated: 31/05/2012
EMA/299783/2012 -
-
List item
Pixuvri : EPAR - Risk-management-plan summary (PDF/52.45 KB)
First published: 02/09/2019
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 |
Les Laboratoires Servier
|
Revision |
22
|
Date of issue of marketing authorisation valid throughout the European Union |
10/05/2012
|
Contact address |
Product information
09/01/2020 Pixuvri - EMEA/H/C/002055 - IA/0049
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.