Agência Nacional de Vigilância Sanitária (Anvisa)

Is Elamipretide (SS-31) legal in Brazil?

Not approvedNo Brazilian registration for elamipretide

Not approved as a medicine here.

Elamipretide has no entry in Anvisa's open-data medicines register (checked 2026-09-29), and no Brazilian application was found. Under Anvisa rules a medicine without a Brazilian registration cannot be marketed.

Last verified 2026-09-29 · how we verify

Molecule

Elamipretide (SS-31) explained →

Country

All rules in Brazil →

Elamipretide (SS-31) elsewhere

AustraliaNot approved
CanadaProhibited
ChinaNot approved
European UnionNot approved
IndiaNot approved
JapanNot approved
MexicoNot approved
New ZealandNot approved
United Arab EmiratesUnverified
United KingdomNot approved
United StatesApproved, restricted

Sources (1)

01Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)Agência Nacional de Vigilância Sanitária (Anvisa) · 2026-09-29 · accessed 2026-09-29