Eurartesim

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piperaquine tetraphosphate / artenimol

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

Overview

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.

This EPAR was last updated on 21/02/2018

Authorisation details

Product details
Name
Eurartesim
Agency product number
EMEA/H/C/001199
Active substance
piperaquine tetraphosphate / artenimol
International non-proprietary name (INN) or common name
piperaquine tetraphosphate / artenimol
Therapeutic area (MeSH)
Malaria
Anatomical therapeutic chemical (ATC) code
P01BF05
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.

Publication details
Marketing-authorisation holder
Alfasigma S.p.A.
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
27/10/2011
Contact address
Viale Sarca 223
20126 Milan
Italy

Product information

14/09/2017 Eurartesim - EMEA/H/C/001199 - T/0029

Contents

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Pharmacotherapeutic group

ANTIPROTOZOALS

Therapeutic indication

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.

Assessment history

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