Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Eurartesim   
Auth. number : EU/1/11/716
INN : piperaquine tetraphosphate / dihydroartemisinin
ATC: Anatomical main group: P - Antiparasitic products
Therapeutic subgroup: P01 - Antiprotozoals
Pharmacological subgroup: P01B - Antimalarials
Chemical subgroup: P01BF - Artemisinin and derivatives, combinations
Chemical substance: P01BF05 - Artenimol and piperaquine
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A
Viale Shakespeare 47, 00144 Roma, Italia

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
31/10/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1199 (2011)7927 of 27/10/2011
02/11/2011 Centralised - Authorisation EMEA/H/C/1199 (2011)7926 of 27/10/2011
13/12/2011 Centralised - Variation EMEA/H/C/1199/N/2
Updated with Decision(2012)2179 of 26/03/2012
28/03/2012 Centralised - Variation EMEA/H/C/1199/II/1/G (2012)2179 of 26/03/2012
04/05/2012 Corrigendum
14/05/2012 Corrigendum
28/04/2014 Centralised - Variation EMEA/H/C/1199/IB/10
28/07/2014 Centralised - Variation EMEA/H/C/1199/N/13