Artesunate Amivas

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artesunate

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

Overview

Artesunate Amivas is a malaria medicine used as initial treatment of severe malaria in adults and children. Malaria is an infection caused by a parasite known as Plasmodium. ‘Severe’ malaria means the disease involves potentially life-threatening symptoms.

Malaria is rare in the EU, and Artesunate Amivas was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 28 February 2020.

Artesunate Amivas contains the active substance artesunate.

This EPAR was last updated on 13/01/2022

Authorisation details

Product details
Name
Artesunate Amivas
Agency product number
EMEA/H/C/005550
Active substance
artesunate
International non-proprietary name (INN) or common name
artesunate
Therapeutic area (MeSH)
Malaria
Anatomical therapeutic chemical (ATC) code
P01BE03
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.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Amivas Ireland Ltd
Date of issue of marketing authorisation valid throughout the European Union
22/11/2021
Contact address

7 Durands Court Parnell Street
Waterford X91 P381
Ireland

Product information

22/11/2021 Artesunate Amivas - EMEA/H/C/005550 -

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

Antiprotozoals

Therapeutic indication

Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children.

Consideration should be given to official guidance on the appropriate use of antimalarial agents.

Assessment history

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