Is Spesolimab 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 Spesolimab, including Spevigo 450 mg per 7.5 ml (60 mg/ml, Solution for infusion, SAR 84631.20).

Is Spesolimab approved by the US FDA?

Drugs@FDA lists 1 application product line for Spesolimab, including SPEVIGO (Prescription).

Is Spesolimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Spesolimab: Spevigo.

Are there safety signals or safety updates for Spesolimab?

US FDA: 1 entry (latest 2025-10-21).

Active substance

Spesolimab

SFDA 1
US FDA 1
EMA 1
Health Canada 2
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
Spevigo 450 mg per 7.5 ml	60 mg/ml	Solution for infusion · Intravenous use	2 Vial	SAR 84631.20	Biological · Prescription	Boehringer Ingelheim Pharma GmbH and Co KG	Valid

Indications — CHI Daman Drug Formulary

PSORIASIS - GENERALIZED PUSTULAR PSORIASIS

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

Product	Strength	Form · route	Applicant	Status	First approved
SPEVIGO	900MG	injectable · intravenous	BOEHRINGER INGELHEIM PHARMACEUTICALS INC	Prescription	1 Sep 2022

EMA European Union — centrally authorised medicines

Spevigo LEO Pharma A/S · Authorised · authorised 9 Dec 2022 · ATC L04AC22

Therapeutic indication (EMA)

Spevigo is indicated for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Spevigo is indicated for the treatment of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SPEVIGO	02536455	60 MG / ML	SOLUTION · INTRAVENOUS	LEO PHARMA INC
SPEVIGO	02550296	150 MG / 1 ML	SOLUTION · SUBCUTANEOUS	LEO PHARMA INC

Safety signals and safety-related labeling changes

US FDA 21 Oct 2025 SPEVIGO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for spesolimab →

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.