Is Mirikizumab 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 Mirikizumab, including OMVOH (100 mg/ml, Solution for injection in pre-filled syringe, SAR 4805.80); OMVOH (100 mg/ml, Solution for injection in pre-filled pen, SAR 4805.80); OMVOH (20 mg/ml, Solution for infusion, SAR 4805.80).

Is Mirikizumab approved by the US FDA?

Drugs@FDA lists 2 application product lines for Mirikizumab, including OMVOH (Prescription); OMVOH (Prescription).

Is Mirikizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mirikizumab: Omvoh.

Are there safety signals or safety updates for Mirikizumab?

US FDA: 1 entry (latest 2025-10-23).

Active substance

Mirikizumab

SFDA 3
US FDA 2
EMA 1
Health Canada 7
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OMVOH	100 mg/ml	Solution for injection in pre-filled syringe · Subcutaneous use	2 Pre-filled syringe	SAR 4805.80	Biological · Prescription	Eli Lilly and Company	Valid
OMVOH	100 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	2 Pre-filled pen	SAR 4805.80	Biological · Prescription	Eli Lilly and Company	Valid
OMVOH	20 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 4805.80	Biological · Prescription	Eli Lilly and Company	Valid

Indications — CHI Daman Drug Formulary

ULCERATIVE COLITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
OMVOH	300MG/15ML	vial · single-use	ELI LILLY AND CO	Prescription	26 Oct 2023
OMVOH	100MG/ML	injectable · subcutaneous	ELI LILLY AND CO	Prescription	26 Oct 2023

EMA European Union — centrally authorised medicines

Omvoh Eli Lilly Nederland B.V. · Authorised · authorised 26 May 2023 · ATC L04AC

Therapeutic indication (EMA)

Omvoh 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 biologic treatment.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OMVOH	02539845	100 MG / ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
OMVOH	02539853	100 MG / ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
OMVOH	02539861	20 MG / ML	SOLUTION · INTRAVENOUS	ELI LILLY CANADA INC
OMVOH	02559218	200 MG / 2 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
OMVOH	02559226	200 ML / 2 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
OMVOH	02559234	200 MG / 2 ML; 100 MG / ML	KIT · SUBCUTANEOUS	ELI LILLY CANADA INC
OMVOH	02559242	200 MG / 2 ML; 100 MG / ML	KIT · SUBCUTANEOUS	ELI LILLY CANADA INC

Safety signals and safety-related labeling changes

US FDA 23 Oct 2025 OMVOH — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for mirikizumab →

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.