Is Tildrakizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Tildrakizumab, including Ilumya (100 mg/ml, Solution for injection in pre-filled syringe, SAR 10036.95).

Is Tildrakizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Tildrakizumab, including ILUMYA (Prescription).

Is Tildrakizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tildrakizumab: Ilumetri.

Are there safety signals or safety updates for Tildrakizumab?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-07-16).

Active substance

Tildrakizumab

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Ilumya	100 mg/ml	Solution for injection in pre-filled syringe · Subcutaneous use	1 Pre-filled syringe	SAR 10036.95	Biological · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

Indications — CHI Daman Drug Formulary

PSORIASIS

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

Product	Strength	Form · route	Applicant	Status	First approved
ILUMYA	100MG/1ML	injectable · injection	SUN PHARMA GLOBAL	Prescription	20 Mar 2018

EMA European Union — centrally authorised medicines

Ilumetri Almirall, S.A. · Authorised · authorised 17 Sep 2018 · ATC L04AC

Therapeutic indication (EMA)

Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ILUMYA	02516098	100 MG / ML	SOLUTION · SUBCUTANEOUS	SUN PHARMACEUTICAL INDUSTRIES LIMITED
ILUMYA	02558904	100 MG / ML	SOLUTION · SUBCUTANEOUS	SUN PHARMACEUTICAL INDUSTRIES LIMITED

Safety signals and safety-related labeling changes

US FDA 16 Jul 2026 ILUMYA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 27 Oct 2022 PRAC signal: Herpes zoster
Action for MAH: update of the product information: No
EMA PRAC 10 Jun 2022 PRAC signal: Herpes zoster
Action for MAH: update of the product information: No

All safety entries for tildrakizumab →

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.