Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Entyvio   
Auth. number : EU/1/14/923
Active substance : vedolizumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA33 - Vedolizumab
(See WHO ATC Index)
Indication: Ulcerative Colitis

Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist.

Crohn’s Disease

Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist.
Marketing Authorisation Holder: Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark
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
27/05/2014 Centralised - Authorisation EMEA/H/C/2782 (2014)3550 of 22/05/2014
15/04/2015 Centralised - Notification EMEA/H/C/2782/N/4
Updated with Decision(2015)5983 of 20/08/2015
10/07/2015 Centralised - Notification EMEA/H/C/2782/N/05
Updated with Decision(2016)8935 of 19/12/2016
24/08/2015 PSUSA - Modification EMEA/H/C/PSUSA/10186/201411 (2015)5983 of 20/08/2015
14/12/2015 Centralised - Variation EMEA/H/C/2782/IAin/09
Updated with Decision(2016)8935 of 19/12/2016
04/04/2016 Centralised - Notification EMEA/H/C/2782/N/14
Updated with Decision(2016)8935 of 19/12/2016
12/05/2016 Centralised - Variation EMEA/H/C/2782/II/12/G
Updated with Decision(2016)8935 of 19/12/2016
14/11/2016 Centralised - Variation EMEA/H/C/2782/IAIN/19
Updated with Decision(2016)8935 of 19/12/2016
08/12/2016 Centralised - Notification EMEA/H/C/2782/N/21
21/12/2016 Centralised - Yearly update (2016)8935 of 19/12/2016