Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: MALARONE
Active substances:
Estonian, English, Latin
ATC code: P01BB51
Dosage form: film-coated tablet
Strength: 100mg+250mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated February 15, 2021)
Package information leaflet (PIL): EST  (last updated February 22, 2023)
Labelling:  (last updated December 21, 2018)
Indication: Prophylaxis of Plasmodium falciparum malaria in adults. Treatment of acute, uncomplicated Plasmodium falciparum malaria in adults and children weighing more than 11 kg. Note: Because Malarone is effective against drug sensitive and drug resistant P. falciparum it is especially recommended for prophylaxis and treatment of P. falciparum malaria where the pathogen may be resistant to other antimalarials. Official guidelines and local information on the prevalence of resistance to antimalarial drugs should be taken into consideration. Official guidelines will normally include WHO and public health authorities guidelines.
Safety features: Yes
Marketing authorization holder: GlaxoSmithKline (Ireland) Limited 
Marketing authorization number: 425503 
Marketing authorization issued on: December 5, 2003 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1129979  MALARONE  film-coated tablet  100mg +250mg 12TK  Prescription      12.02.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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