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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1546703
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Name of medicinal product:
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EURARTESIM
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Active substances:
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ATC code:
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P01BF05
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Dosage form:
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film-coated tablet
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Route of administration:
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oral use
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Strengh:
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20mg+160mg
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Amount in package:
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3TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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).
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Alfasigma S.p.A.
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Marketing authorization number:
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EU/1/11/716
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Marketing authorization issued on:
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October 27, 2011
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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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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