🇪🇺 TECOVIRIMAT MONOHYDRATE in European Union

EMA authorised TECOVIRIMAT MONOHYDRATE on 6 January 2022

Marketing authorisation

EMA — authorised 6 January 2022

  • Application: EMEA/H/C/005248
  • Marketing authorisation holder: SIGA Technologies Netherlands B.V.
  • Local brand name: Tecovirimat SIGA
  • Indication: Tecovirimat SIGA is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg: Smallpox Monkeypox 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 13 kg (see sections 4.4 and 5.1). Tecovirimat SIGA should be used in accordance with official recommendations.
  • Pathway: exceptional circumstances
  • Status: approved

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TECOVIRIMAT MONOHYDRATE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is TECOVIRIMAT MONOHYDRATE approved in European Union?

Yes. EMA authorised it on 6 January 2022.

Who is the marketing authorisation holder for TECOVIRIMAT MONOHYDRATE in European Union?

SIGA Technologies Netherlands B.V. holds the EU marketing authorisation.