Summary of Product Characteristics
This section provides European Commission approval and labeling information for Entyvio in Ulcerative Colitis and Crohn's Disease.
Entyvio Therapeutic Indications
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.
Summary of Product CharacteristicsDownload the European Summary of Product Characteristics for comprehensive clinical, pharmacological and prescribing information about Entyvio.
Entyvio Newsroom
On this page you will find the latest press releases and relevant news about Entyvio. You can request additional information on Entyvio here.
May 27, 2014
Takeda Receives European Commission Marketing Authorisation for Entyvio® (vedolizumab) for the Treatment of Ulcerative Colitis and Crohn’s Disease
Takeda Receives European Commission Marketing Authorisation for Entyvio® (vedolizumab) for the Treatment of Ulcerative Colitis and Crohn’s Disease
March 21, 2014
Takeda Receives Positive CHMP Opinion for Entyvio® (vedolizumab) in Europe for the Treatment of Ulcerative Colitis and Crohn's Disease
August 21, 2013
Data Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to Severely Active Ulcerative Colitis and Crohn's Disease
Takeda Receives Positive CHMP Opinion for Entyvio® (vedolizumab) in Europe for the Treatment of Ulcerative Colitis and Crohn's Disease
August 21, 2013
Data Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to Severely Active Ulcerative Colitis and Crohn's Disease
March 7, 2013
Takeda Submits Marketing Authorisation Application for Vedolizumab in Moderately to Severely Active Ulcerative Colitis and Crohn's Disease in the European
Takeda Submits Marketing Authorisation Application for Vedolizumab in Moderately to Severely Active Ulcerative Colitis and Crohn's Disease in the European
May 11, 2012
Takeda Announces GEMINI II Trial of Vedolizumab in Patients with Moderately to Severely Active Crohn’s Disease Met Primary Endpoints of Improvement in Clinical Remission in Induction and Maintenance Phases
February 12, 2012Takeda Announces Primary Endpoints Met for Pivotal Phase 3 Trial of VEDOLIZUMAB in Patients with Moderately to Severely Active Ulcerative Colitis Who Have Failed at Least One Conventional Therapy -GEMINI I Trial Met Primary Endpoints of Improvements in Clinical Response in Induction and Clinical Remission in Maintenance
Takeda Announces GEMINI II Trial of Vedolizumab in Patients with Moderately to Severely Active Crohn’s Disease Met Primary Endpoints of Improvement in Clinical Remission in Induction and Maintenance Phases
February 12, 2012Takeda Announces Primary Endpoints Met for Pivotal Phase 3 Trial of VEDOLIZUMAB in Patients with Moderately to Severely Active Ulcerative Colitis Who Have Failed at Least One Conventional Therapy -GEMINI I Trial Met Primary Endpoints of Improvements in Clinical Response in Induction and Clinical Remission in Maintenance