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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|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)
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.
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|
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.
|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/5|
|24/08/2015||PSUSA - Modification||EMEA/H/C/PSUSA/10186/201411||(2015)5983 of 20/08/2015|