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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20/01/2020 Eurartesim - EMEA/H/C/001199 - II/0036
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.