Pixuvri

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Expired

This medicine's authorisation has expired

pixantrone dimaleate
MedicineHumanExpired
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Pixuvri has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

Pixuvri : EPAR - Summary for the public

Reference Number: EMA/299783/2012

English (EN) (106.41 KB - PDF)

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български (BG) (210.71 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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español (ES) (111.42 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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čeština (CS) (140.44 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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dansk (DA) (95.85 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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Deutsch (DE) (96.38 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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eesti keel (ET) (154.52 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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ελληνικά (EL) (219.06 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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français (FR) (157.71 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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italiano (IT) (98.75 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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latviešu valoda (LV) (153.26 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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lietuvių kalba (LT) (141.13 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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magyar (HU) (120.92 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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Malti (MT) (141.26 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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Nederlands (NL) (94.9 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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polski (PL) (138.88 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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português (PT) (154.37 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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română (RO) (136.21 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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slovenčina (SK) (124.99 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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slovenščina (SL) (183.44 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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Suomi (FI) (155.62 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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svenska (SV) (106.47 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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Pixuvri : EPAR - Risk-management-plan summary

English (EN) (128.11 KB - PDF)

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Product information

Pixuvri : EPAR - Product Information

English (EN) (1.16 MB - PDF)

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български (BG) (4.26 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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español (ES) (765.76 KB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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čeština (CS) (4.45 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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dansk (DA) (1.22 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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Deutsch (DE) (1.67 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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eesti keel (ET) (1.61 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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ελληνικά (EL) (2.46 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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français (FR) (822.25 KB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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hrvatski (HR) (1.7 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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íslenska (IS) (1.29 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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italiano (IT) (1.3 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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latviešu valoda (LV) (4.38 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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lietuvių kalba (LT) (1.78 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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magyar (HU) (1.82 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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Malti (MT) (1.83 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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Nederlands (NL) (1.46 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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norsk (NO) (1.15 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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polski (PL) (2.04 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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português (PT) (1.74 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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română (RO) (2.02 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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slovenčina (SK) (4.37 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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slovenščina (SL) (1.88 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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Suomi (FI) (1.47 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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svenska (SV) (1.41 MB - PDF)

First published: 31/05/2012Last updated: 07/12/2021
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Latest procedure affecting product information: N/0050
09/11/2021
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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:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Pixuvri : EPAR - All Authorised presentations

English (EN) (30.44 KB - PDF)

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български (BG) (69.84 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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español (ES) (31.94 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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čeština (CS) (61.74 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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dansk (DA) (31.54 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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Deutsch (DE) (31.86 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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eesti keel (ET) (32.15 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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ελληνικά (EL) (67.18 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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français (FR) (30.91 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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hrvatski (HR) (50.11 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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íslenska (IS) (39.52 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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italiano (IT) (31.15 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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latviešu valoda (LV) (61.32 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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lietuvių kalba (LT) (60.54 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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magyar (HU) (46.01 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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Malti (MT) (72.54 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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Nederlands (NL) (31.54 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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norsk (NO) (39.47 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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polski (PL) (60.71 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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português (PT) (32.31 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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română (RO) (60.34 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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slovenčina (SK) (61.33 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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slovenščina (SL) (31.15 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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Suomi (FI) (31.11 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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svenska (SV) (32.02 KB - PDF)

First published: 31/05/2012Last updated: 31/05/2012
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Product details

Name of medicine
Pixuvri
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

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.

Authorisation details

EMA product number
EMEA/H/C/002055
Marketing authorisation holder
Les Laboratoires Servier

Les Laboratoires Servier
50 rue Carnot
F-92284 Suresnes Cedex
France

Marketing authorisation issued
10/05/2012
Revision
23

Assessment history

Pixuvri : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (473.61 KB - PDF)

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Pixuvri-H-C-2055-R-0046 : EPAR - Assessment report- Renewal

Reference Number: EMA/250839/2019

English (EN) (6.68 MB - PDF)

First published:
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Pixuvri-H-C-2055-PSUV-0015 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/500946/2014

English (EN) (101.37 KB - PDF)

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Pixuvri : EPAR - Public assessment report

AdoptedReference Number: EMA/309145/2012

English (EN) (2.36 MB - PDF)

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CHMP summary of positive opinion for Pixuvri

AdoptedReference Number: EMA/CHMP/102366/2012

English (EN) (80.58 KB - PDF)

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More information on Pixuvri

Public statement on Pixuvri: Expiry of the marketing authorisation in the European Union

Reference Number: EMA/272680/2024

English (EN) (117.49 KB - PDF)

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