Tecovirimat SIGA

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tecovirimat monohydrate

Authorised
This medicine is authorised for use in the European Union.

Overview

Tecovirimat SIGA is a medicine to treat smallpox, monkeypox and cowpox, three infections caused by viruses belonging to the same family (orthopoxviruses). It is also used to treat complications that can happen following vaccination against smallpox. Tecovirimat SIGA is used in adults and children weighing at least 13 kg.

It contains the active substance tecovirimat.

This EPAR was last updated on 28/01/2022

Authorisation details

Product details
Name
Tecovirimat SIGA
Agency product number
EMEA/H/C/005248
Active substance
Tecovirimat
International non-proprietary name (INN) or common name
tecovirimat monohydrate
Therapeutic area (MeSH)
  • Poxviridae Infections
  • Cowpox
  • Monkeypox
  • Vaccinia
  • Smallpox
Anatomical therapeutic chemical (ATC) code
J05AX24
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
SIGA Technologies Netherlands B.V.
Date of issue of marketing authorisation valid throughout the European Union
06/01/2022
Contact address

Prinsenhil 29
4825 AX Breda
Netherlands

Product information

Tecovirimat SIGA - EMEA/H/C/005248 -

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic 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.

Assessment history

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