Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: EURARTESIM
Active substances:
Artenimol+Piperaquine tetraphosphate
Estonian, English, Latin
ATC code: P01BF05
Dosage form: film-coated tablet
Strength: 40mg+320mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Indication: Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, adolescents, 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 medicinal products, including information on the prevalence of resistance to artenimol/piperaquine in the geographical region where the infection was acquired (see section 4.4).
Safety features: Yes
Marketing authorization holder: Alfasigma S.p.A. 
Marketing authorization number: EU/1/11/716 
Marketing authorization issued on: October 27, 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1546714  EURARTESIM  film-coated tablet  40mg +320mg 3TK  Prescription           
1546725  EURARTESIM  film-coated tablet  40mg +320mg 6TK  Prescription           
1546736  EURARTESIM  film-coated tablet  40mg +320mg 9TK  Prescription           
1546747  EURARTESIM  film-coated tablet  40mg +320mg 12TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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