Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1546736
Name of medicinal product: EURARTESIM
Active substances:
Artenimol+Piperaquine tetraphosphate
Estonian, English, Latin
ATC code: P01BF05
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 40mg+320mg
Amount in package: 9TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: September 16, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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