Artesunate Amivas
artesunate
Table of contents
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.
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Artesunate Amivas : EPAR - Medicine overview (PDF/128.53 KB)
First published: 04/01/2022
EMA/531550/2021 -
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Artesunate Amivas : EPAR - Risk-management-plan summary (PDF/130.34 KB)
First published: 04/01/2022
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 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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Amivas Ireland Ltd
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
22/11/2021
|
Contact address |
Suite 5, Second Floor Waterford |
Product information
08/11/2023 Artesunate Amivas - EMEA/H/C/005550 - N/0010
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
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.