Tecovirimat SIGA
tecovirimat monohydrate
Table of contents
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.
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Tecovirimat SIGA : EPAR - Medicine Overview (PDF/96.05 KB)
First published: 28/01/2022
EMA/44982/2022 -
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Tecovirimat SIGA - EPAR - Risk management plan summary (PDF/101.5 KB)
First published: 28/01/2022
Authorisation details
Product details | |
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Name |
Tecovirimat SIGA
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Agency product number |
EMEA/H/C/005248
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Active substance |
Tecovirimat
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International non-proprietary name (INN) or common name |
tecovirimat monohydrate
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J05AX24
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Additional 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 | |
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Marketing-authorisation holder |
SIGA Technologies Netherlands B.V.
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
06/01/2022
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Contact address |
Prinsenhil 29 |
Product information
15/03/2023 Tecovirimat SIGA - EMEA/H/C/005248 - IB/0007
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.