Besponsa

RSS

inotuzumab ozogamicin

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

Overview

This is a summary of the European public assessment report (EPAR) for Besponsa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Besponsa.

For practical information about using Besponsa, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 01/02/2018

Authorisation details

Product details
Name
Besponsa
Agency product number
EMEA/H/C/004119
Active substance
inotuzumab ozogamicin
International non-proprietary name (INN) or common name
inotuzumab ozogamicin
Therapeutic area (MeSH)
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anatomical therapeutic chemical (ATC) code
L01XC
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.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Pfizer Limited
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
29/06/2017
Contact address
821 Ramsgate Road Sandwich
Kent CT13 9NJ
United Kingdom

Product information

05/12/2017 Besponsa - EMEA/H/C/004119 - N/0002

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

Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).

Assessment history

How useful was this page?

Add your rating