Is Artesunate approved by the US FDA?

Drugs@FDA lists 1 application product line for Artesunate, including ARTESUNATE (Prescription).

Is Artesunate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Artesunate: Artesunate Amivas.

Is Artesunate on the WHO Model List of Essential Medicines?

Yes — 6.5.3.1. Antimalarial medicines > Medicines for curative treatment (core list): Malaria due to Plasmodium falciparum; Malaria due to Plasmodium vivax.

Are there safety signals or safety updates for Artesunate?

US FDA: 1 entry (latest 2022-02-04).

Active substance

Artesunate

US FDA 1
EMA 2
Health Canada 1
WHO EML 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ARTESUNATE	110MG/VIAL	powder · intravenous	AMIVAS	Prescription	26 May 2020

EMA European Union — centrally authorised medicines

Artesunate Amivas Amivas Ireland Ltd · Authorised · authorised 22 Nov 2021 · ATC P01BE03

Therapeutic indication (EMA)

Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children. Consideration should be given to official guidance on the appropriate use of antimalarial agents.

Garsun B And O Pharm · Application withdrawn · ATC P01BE03

Therapeutic indication (EMA)

Treatment of severe malaria

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AMIVAS-ARTESUNATE	02559056	110 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	AMIVAS IRELAND LTD.

WHO WHO Model List of Essential Medicines (2025)

6.5.3.1. Antimalarial medicines > Medicines for curative treatment · core
Malaria due to Plasmodium falciparum; Malaria due to Plasmodium vivax
Parenteral > General injections > IV: 60 mg in vial powder for injection; 30 mg in vial powder for injection; 120 mg in vial powder for injection | Local > Rectal > Other: 100 mg capsules (EMLc)

Safety signals and safety-related labeling changes

US FDA 4 Feb 2022 ARTESUNATE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for artesunate →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.