Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ARTESUNATE AMIVAS
Active substances:
Artesunate
Estonian, English, Latin
ATC code: P01BE03
Dosage form: powder and solvent for solution for injection
Strength: 110mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children (see sections 4.2 and 5.1). Consideration should be given to official guidance on the appropriate use of antimalarial agents.
Safety features: Yes
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Amivas Ireland Limited 
Marketing authorization number: EU/1/21/1582 
Marketing authorization issued on: November 22, 2021 
Marketing authorization expires on: November 24, 2026 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported Additional information
1867721  ARTESUNATE AMIVAS  powder and solvent for solution for injection  110mg 2TK  Prescription         
1867732  ARTESUNATE AMIVAS  powder and solvent for solution for injection  110mg 4TK  Prescription         
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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