Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Blincyto   
Auth. number : EU/1/15/1047
Active substance : blinatumomab
Orphan market exclusivity for "Treatment of acute lymphoblastic leukaemia" (based on designation EU/3/09/650) started on 25/11/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 25/11/2025
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC19 - blinatumomab
(See WHO ATC Index)
Indication: BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B precursor acute lymphoblastic leukaemia (ALL).

BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
Marketing Authorisation Holder: Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/11/2015 Centralised - Authorisation EMEA/H/C/3731 (2015)8389 of 23/11/2015
28/04/2016 Centralised - Variation EMEA/H/C/3731/IB/2
Updated with Decision(2016)6238 of 22/09/2016
5/08/2016 Centralised - Variation EMEA/H/C/3731/IB/5
Updated with Decision(2016)6881 of 21/10/2016
26/09/2016 Centralised - Annual renewal EMEA/H/C/3731/R/4 (2016)6238 of 22/09/2016
25/10/2016 Centralised - 2-Monthly update EMEA/H/C/3731/II/3 (2016)6881 of 21/10/2016
28/07/2017 Centralised - Variation EMEA/H/C/3731/IB/16
Updated with Decision(2018)1956 of 23/03/2018
20/09/2017 PSUSA - Modification EMEA/H/C/PSUSA/10460/201612 (2017)6431 of 18/09/2017
10/11/2017 Centralised - Variation EMEA/H/C/3731/IA/853/G
Updated with Decision(2018)1956 of 23/03/2018
27/03/2018 PSUSA - Modification EMEA/H/C/3731/PSUSA/10460/201706 (2018)1956 of 23/03/2018
23/04/2018 Centralised - Annual renewal EMEA/H/C/3731/R/13 (2018)2515 of 19/04/2018
4/06/2018 Centralised - Variation EMEA/H/C/3731/IG/946
Updated with Decision(2018)5706 of 23/08/2018
20/06/2018 Centralised - Authorisation - Switch to non-conditional EMEA/H/C/3731/II/9 (2018)3953 of 18/06/2018
27/08/2018 Centralised - 2-Monthly update EMEA/H/C/3731/II/18 (2018)5706 of 23/08/2018
22/01/2019 Centralised - 2-Monthly update EMEA/H/C/3731/II/11 (2019)588 of 18/01/2019