Entyvio® (vedolizumab) 300mg
Product Overview
| Generic Name | Entyvio® (vedolizumab) 300mg |
| Brand Name(s) | Entyvio® |
| Category | Antibodies, monoclonal |
| Form | IV: powder for concentrate for solution for infusion (vial |
| Strength | 300 mg/vial (to be reconstituted and infused) |
| Therapeutic Class | Integrin (α4β7) receptor antagonist / ILGI; gut-selective immunosuppressant for IBD. |
| ATC Code | L04AA33 |
Manufacturing & Regulatory
| Manufacturer | Takeda Pharma A/S |
| GMP Compliance | WHO-GMP |
| DMF/CEP | U.S. approval is via BLA 125476 |
| COFEPRIS | 010.000.6345.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
Logistics & Export
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | GHS SDS available |
| CTD Summary (PDF) | Not publicly available as parallel traded molecule |
Special Notes
Entyvio® (vedolizumab) is a gut-selective humanized mAb that binds integrin α4β7, inhibiting lymphocyte trafficking to the GI tract. It is indicated for adults with moderately to severely active ulcerative colitis or Crohn’s disease who had inadequate response, lost response, or intolerance to conventional therapy or anti-TNF agents.