Blincyto

RSS

blinatumomab

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

Overview

Blincyto is a medicine used to treat a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above 1 year of age when the cancer has come back or has not improved with previous treatment.

Blincyto is used for patients who are ‘Philadelphia-chromosome-negative’ which means that the patients do not have an abnormal chromosome called the Philadelphia chromosome, and in patients who have the protein CD19 on their white blood cells (CD19-positive).

Blincyto contains the active substance blinatumomab and is used on its own.

ALL is rare, and Blincyto was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 July 2009.

This EPAR was last updated on 18/10/2018

Authorisation details

Product details
Name
Blincyto
Agency product number
EMEA/H/C/003731
Active substance
blinatumomab
International non-proprietary name (INN) or common name
blinatumomab
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
Amgen Europe B.V.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
23/11/2015
Contact address
Minervum 7061
4817 ZK Breda
The Netherlands

Product information

23/08/2018 Blincyto - EMEA/H/C/003731 - II/0018

Contents

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

Blincyto is indicated for the treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).

Assessment history

How useful was this page?

Add your rating
Average
1 rating