Tecovirimat SIGA (tecovirimat monohydrate)
- Region
- 🇪🇺 EU
- Active substance
- tecovirimat monohydrate
- Company
- SIGA Technologies Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Poxviridae Infections; Cowpox; Monkeypox; Vaccinia; Smallpox
- CHMP opinion
- Thu 11 Nov 2021
- EU approval
- Thu 06 Jan 2022
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005248
- ATC
- J05AX24
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
Tecovirimat SIGA: EC decision
Article 20 procedures; European Commission final decision · source
Tecovirimat SIGA (tecovirimat monohydrate): DHPC sent to healthcare professionals
Restriction of indication; Poxviridae Infections, Cowpox, Monkeypox, Vaccinia, Smallpox · source
Tecovirimat SIGA: CHMP opinion
Article 20 procedures; European Commission final decision · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.