US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| TPOXX | 200MG | capsule · oral | SIGA TECHNOLOGIES | Prescription | 13 Jul 2018 |
| TPOXX | 200MG/20ML (10MG/ML) | solution · intravenous | SIGA TECHNOLOGIES | Prescription | 18 May 2022 |
EMA European Union — centrally authorised medicines
Tecovirimat SIGA SIGA Technologies Netherlands B.V. · Authorised · authorised 6 Jan 2022 · ATC J05AX24
Therapeutic indication (EMA)
Tecovirimat SIGA is indicated for the treatment of the following viral infections in adults and children with body weight at least 13kg: Smallpox Cowpox Tecovirimat SIGA is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13kg . Tecovirimat SIGA should be used in accordance with official recommendations.
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.