Vedolizumab
Monoclonal Antibodies
Sold as ENTYVIO
- Drug class
- Monoclonal Antibodies
- Availability
- See label
- Routes
- Subcutaneous, Intravenous
- Markets covered
- 3
- Products on record
- 20
Overview
Vedolizumab is an active pharmaceutical ingredient in the Monoclonal Antibodies group (L04AG). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 16 | May 22, 2026 |
| CA Canada | Health Canada | 3 | March 30, 2026 |
| EU European Union | EMA | 1 | March 3, 2026 |
GBUnited Kingdom· MHRA
16 products
Uses
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.
How to take
CACanada· Health Canada
3 products
Uses
ENTYVIO® (vedolizumab) is indicated for:
Ulcerative Colitis (Adults ≥ 18 years) the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a tumor necrosis factor-alpha (TNFα) antagonist.
Crohn's Disease (Adults ≥ 18 years) 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 immunomodulators or a TNFα antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids (see 14 Clinical Trials).
1 Pediatrics • Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Entyvio® in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
EUEuropean Union· EMA
1 product
Uses
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.
Pouchitis Entyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.
Drug interactions
Known interactions involving Vedolizumab. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB154750074 · revised May 15, 2026
- [2]Health Canada (DPD) · 02436841 · revised March 30, 2026
- [3]European Medicines Agency · EMEA/H/C/002782 · revised March 3, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.