Besponsa
inotuzumab ozogamicin
Table of contents
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.
Authorisation details
Product details | |
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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 | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
28/06/2017
|
Contact address |
Product information
05/10/2018 Besponsa - EMEA/H/C/004119 - IB/0008
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).