Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: IMBRUVICA   
Auth. number : EU/1/14/945
Active substance : Ibrutinib
Orphan market exclusivity for "Treatment of chronic lymphocytic leukaemia" (based on designation EU/3/12/984) started on 23/10/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 23/10/2024
Orphan market exclusivity for "Treatment of mantle cell lymphoma" (based on designation EU/3/13/1115) started on 23/10/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 23/10/2024
Orphan market exclusivity for "Treatment of lymphoplasmacytic lymphoma" (based on designation EU/3/14/1264) started on 7/07/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 7/07/2025
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE27 - ibrutinib
(See WHO ATC Index)
Indication: IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
IMBRUVICA as a single agent is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)
IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
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 Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/10/2014 Centralised - Authorisation EMEA/H/C/3791 (2014)7873 of 21/10/2014
26/02/2015 Centralised - Variation EMEA/H/C/3791/II/3
Updated with Decision(2015)4704 of 03/07/2015
26/02/2015 Centralised - Variation EMEA/H/C/3791/II/4
Updated with Decision(2015)4704 of 03/07/2015
7/07/2015 Centralised - 2-Monthly update EMEA/H/C/3791/II/1 (2015)4704 of 3/07/2015
23/07/2015 Centralised - Variation EMEA/H/C/3791/II/8/G
Updated with Decision(2016)3293 of 26/05/2016
22/10/2015 Centralised - Variation EMEA/H/C/3791/II/7/G
Updated with Decision(2016)3293 of 26/05/2016
25/02/2016 Centralised - Variation EMEA/H/C/3791/II/13
Updated with Decision(2016)3293 of 26/05/2016
30/05/2016 Centralised - 2-Monthly update EMEA/H/C/3791/II/16 (2016)3293 of 26/05/2016
21/07/2016 Centralised - Variation EMEA/H/C/3791/II/24
Updated with Decision(2016)5576 of 25/08/2016
29/08/2016 Centralised - 2-Monthly update EMEA/H/C/3791/II/17/G (2016)5576 of 25/08/2016
15/12/2016 Centralised - Variation EMEA/H/C/3791/II/27/G
Updated with Decision(2017)1308 of 17/02/2017
21/02/2017 PSUSA - Modification EMEA/H/C/PSUSA/10301/201605 (2017)1308 of 17/02/2017
23/02/2017 Centralised - Variation EMEA/H/C/3791/II/25
Updated with Decision(2017)5936 of 24/08/2017
18/05/2017 Centralised - Variation EMEA/H/C/3791/II/29
Updated with Decision(2017)5936 of 24/08/2017
18/05/2017 Centralised - Variation EMEA/H/C/3791/IB/35
Updated with Decision(2017)5936 of 24/08/2017
28/08/2017 PSUSA - Modification EMEA/H/C/PSUSA/10301/201611 (2017)5936 of 24/08/2017
28/09/2017 Centralised - Variation EMEA/H/C/3791/II/33/G
Updated with Decision(2018)951 of 09/02/2018
13/02/2018 PSUSA - Modification EMEA/H/C/PSUSA/10301/201705 (2018)951 of 9/02/2018
31/05/2018 Centralised - Variation EMEA/H/C/3791/II/42
Updated with Decision(2018)5711 of 23/08/2018
3/07/2018 Centralised - Variation EMEA/H/C/3791/X/37 (2018)4245 of 29/06/2018
27/08/2018 PSUSA - Modification EMEA/H/C/PSUSA/10301/201711 (2018)5711 of 23/08/2018