European Medicines Agency (EMA) with the European Commission; national competent authorities in each member state
Is Elamipretide (SS-31) legal in European Union?
Not approvedNo EU marketing authorisation; only EU orphan designations exist
Not approved as a medicine here.
Elamipretide has no EU marketing authorisation. It holds two EU orphan designations (Barth syndrome, designated 20 May 2021, and myopathic mitochondrial DNA depletion syndrome, designated 16 May 2022). An orphan designation is a development incentive and not an approval. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation.
Last verified 2026-09-29 · how we verify
Elamipretide (SS-31) elsewhere
Sources (3)
- 01EU/3/21/2430: orphan designation for elamipretide (Barth syndrome)European Medicines Agency · 2021-05-20 · accessed 2026-09-29
- 02EMA medicines data (JSON report): human and veterinary medicines, with authorisation statusEuropean Medicines Agency · 2026-09-29 · accessed 2026-09-29
- 03Union Register of medicinal products for human useEuropean Commission · 2026-09-29 · accessed 2026-09-29