Pixuvri

Expired

This medicine's authorisation has expired

pixantrone dimaleate

Overview

The marketing authorisation for Pixuvri (Pixantrone) expired on 12 June 2024 following the decision of the marketing authorisation holder, Les Laboratoires Servier, not to apply for a renewal of the marketing authorisation. Les Laboratoires Servier confirmed that it did not apply for renewal of the authorisation due to the lack of demand for this product. Pixuvri was granted marketing authorisation in the European Union (EU) on 10 May 2012 for the treatment of multiply relapsed or refractory aggressive non-Hodgkin lymphomas. 

The marketing authorisation was a conditional marketing authorisation which was subsequently converted to a full marketing authorisation in 2019 and was valid for a 5-year period. Therapeutic alternatives are available throughout the European Union. The European Public Assessment Report (EPAR) for Pixuvri is updated to indicate that the marketing authorisation is no longer valid.

Pixuvri : EPAR - Summary for the public

Reference Number: EMA/299783/2012

Pixuvri : EPAR - Risk-management-plan summary

Product information

Pixuvri : EPAR - Product Information

Pixuvri : EPAR - All Authorised presentations

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

• Opinion adopted:
  16/02/2012
• Marketing authorisation issued:
  10/05/2012
• Expiry of marketing authorisation:
  12/06/2024
• Revision:
  23

Assessment history

Changes since initial authorisation of medicine

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

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

Reference Number: EMA/250839/2019

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

Initial marketing authorisation documents

Pixuvri : EPAR - Public assessment report

AdoptedReference Number: EMA/309145/2012

CHMP summary of positive opinion for Pixuvri

AdoptedReference Number: EMA/CHMP/102366/2012