EMA — authorised 28 November 2025
- Application: EMEA/H/C/006379
- Marketing authorisation holder: Janssen Cilag International NV
- Local brand name: Imaavy
- Indication: 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.
- Status: approved
On 28 November 2025, the European Medicines Agency (EMA) approved Imaavy for marketing in the European Union. 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. This approval allows Janssen Cilag International NV to market Imaavy in the EU for the treatment of gMG patients with specific antibody profiles.