Is Vedolizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Vedolizumab, including ENTYVIO (108 mg, Solution for injection, SAR 4079.15); ENTYVIO 300 mg powder for concentrate for solution for infusion (300 mg, Powder for concentrate for solution for infusion, SAR 7019.30).

Is Vedolizumab approved by the US FDA?

Drugs@FDA lists 5 application product lines for Vedolizumab, including ENTYVIO (Prescription); ENTYVIO (Prescription); ENTYVIO (Prescription); ENTYVIO (Prescription); ENTYVIO (Prescription).

Is Vedolizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vedolizumab: Entyvio.

Are there safety signals or safety updates for Vedolizumab?

EMA PRAC: 3 entries; US FDA: 2 entries (latest 2026-02-25).

Active substance

Vedolizumab

SFDA 3
US FDA 5
EMA 1
Health Canada 3
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ENTYVIO	108 mg	Solution for injection · Subcutaneous use	2 Pre-filled syringe	SAR 4079.15	Biological · Prescription	TAKEDA PHARMA A/S	Valid
ENTYVIO	108 mg	Solution for injection · Subcutaneous use	2 Pre-filled pen	SAR 4079.15	Biological · Prescription	TAKEDA PHARMA A/S	Valid
ENTYVIO 300 mg powder for concentrate for solution for infusion	300 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 7019.30	Biological · Prescription	TAKEDA PHARMA A/S	Valid

Indications — CHI Daman Drug Formulary

CROHN'S DISEASE; DIARRHEA; ULCERATIVE COLITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ENTYVIO	300MG	injectable · injection	TAKEDA PHARMS USA	Prescription	20 May 2014
ENTYVIO	300MG	injectable · intravenous	TAKEDA PHARMS USA	Prescription	27 Sep 2023
ENTYVIO	108MG/0.68ML	injectable · injection	TAKEDA PHARMS USA	Prescription	27 Sep 2023
ENTYVIO	300MG	injectable · intravenous	TAKEDA PHARMS USA	Prescription	18 Apr 2024
ENTYVIO	108MG/0.68ML	injectable · subcutaneous	TAKEDA PHARMS USA	Prescription	18 Apr 2024

EMA European Union — centrally authorised medicines

Entyvio Takeda Pharma A/S · Authorised · authorised 22 May 2014

Therapeutic indication (EMA)

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 (TNF?) 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 (TNF?) 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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ENTYVIO	02436841	300 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	TAKEDA CANADA INC
ENTYVIO	02497867	108 MG / 0.68 ML	SOLUTION · SUBCUTANEOUS	TAKEDA CANADA INC
ENTYVIO	02497875	108 MG / 0.68 ML	SOLUTION · SUBCUTANEOUS	TAKEDA CANADA INC

Safety signals and safety-related labeling changes

US FDA 25 Feb 2026 ENTYVIO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 25 Feb 2026 ENTYVIO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 3 Sep 2020 PRAC signal: Evans’ syndrome, autoimmune haemolytic anaemia, immune thrombocytopenic purpura
Action for MAH: update of the product information: No
EMA PRAC 17 Apr 2020 PRAC signal: Evans’ syndrome, autoimmune haemolytic anaemia, immune thrombocytopenic purpura
Action for MAH: update of the product information: No
EMA PRAC 13 May 2016 PRAC signal: Hepatotoxicity
Action for MAH: update of the product information: No

All safety entries for vedolizumab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.