Is Nipocalimab approved by the US FDA?

Drugs@FDA lists 1 application product line for Nipocalimab, including IMAAVY (Prescription).

Is Nipocalimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Nipocalimab: Imaavy.

Are there safety signals or safety updates for Nipocalimab?

US FDA: 1 entry (latest 2026-08-24).

Active substance

Nipocalimab

US FDA 1
EMA 1
Health Canada 2
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
IMAAVY	300MG/1.62ML(185MG/ML); 1200MG/6.5ML(185MG/ML)	injectable · injection	JANSSEN BIOTECH	Prescription	29 Apr 2025

EMA European Union — centrally authorised medicines

Imaavy Janssen Cilag International NV · Authorised · authorised 28 Nov 2025 · ATC L04AL03

Therapeutic indication (EMA)

Imaavy is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti‑acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IMAAVY	02563509	300 MG / 1.62 ML	SOLUTION · INTRAVENOUS	JANSSEN INC
IMAAVY	02563517	1200 MG / 6.5 ML	SOLUTION · INTRAVENOUS	JANSSEN INC

Safety signals and safety-related labeling changes

US FDA 24 Aug 2026 IMAAVY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations

All safety entries for nipocalimab →

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.