Is Nemolizumab approved by the US FDA?

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

Is Nemolizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Nemolizumab: Nemluvio.

Are there safety signals or safety updates for Nemolizumab?

EMA PRAC: 1 entry; US FDA: 2 entries (latest 2025-10-30).

Active substance

Nemolizumab

US FDA 2
EMA 1
Health Canada 1
Safety 3

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
NEMLUVIO	30MG	injectable · injection	GALDERMA LABS LP	Prescription	12 Aug 2024
NEMLUVIO	30mg	injectable · injection	GALDERMA LABS LP	Prescription	13 Dec 2024

EMA European Union — centrally authorised medicines

Nemluvio Galderma International · Authorised · authorised 12 Feb 2025 · ATC D11AH12

Therapeutic indication (EMA)

Atopic dermatitis (AD) Nemluvio is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy. Prurigo nodularis (PN) Nemluvio is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NEMLUVIO	02563673	30 MG / 0.49 ML	POWDER FOR SOLUTION · SUBCUTANEOUS	GALDERMA CANADA INC.

Safety signals and safety-related labeling changes

EMA PRAC 30 Oct 2025 PRAC signal: Erythema multiforme
Action for MAH: update of the product information: No
US FDA 26 Jun 2025 NEMLUVIO — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Jun 2025 NEMLUVIO — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for nemolizumab →

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.