Tecovirimat Siga

Tecovirimat (SIGA) Recall Summary The antiviral drug tecovirimat, used to treat poxvirus infections including monkeypox and smallpox, is being restricted in the European Union. The approved uses for this medication are being limited, classified as a Class II recall affecting the EU market.

Product
Active substances: tecovirimat monohydrate. Therapeutic area: Poxviridae Infections;Cowpox;Monkeypox;Vaccinia;Smallpox. ATC code: J05AX24
Reason
Restriction of indication
Classification
Class II
Category
drug recall
Country
European Union
Agency
EMA-DHPC
Recall date
2026-05-11
Status
Ongoing
Distribution
European Union

Official recall notice from EMA-DHPC

Recall details on Nibble Recalls: https://trynibble.app/recalls/d775fdac-79fb-4df4-8c6c-6f2cd0398a8f