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ARTESUNATE AMIVAS
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1867732
Name of medicinal product:
ARTESUNATE AMIVAS
Active substances:
Artesunate
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:
4TK
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
Labelling:
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
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
Prices
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
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