piperaquine tetraphosphate / artenimol
This is a summary of the European public assessment report (EPAR) for Eurartesim. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eurartesim.
Eurartesim : EPAR - Summary for the public (PDF/80.9 KB)
First published: 28/11/2011
Last updated: 26/09/2016
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Via Ragazzi del '99, n.5
22/07/2021 Eurartesim - EMEA/H/C/001199 - IB/0038/G
This medicine’s product information is available in all official EU languages.
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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.
Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, children and infants 6 months and over and weighing 5 kg or more.
Consideration should be given to official guidance on the appropriate use of antimalarial agents.