Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1867721
Name of medicinal product: ARTESUNATE AMIVAS
Active substances:
Estonian, English, Latin
ATC code: P01BE03
Dosage form: powder and solvent for solution for injection
Route of administration: intramuscular use
Strengh: 110mg
Amount in package: 2TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Last imported to Estonia: Never imported to Estonia
: 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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: December 1, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere