Artesunate Amivas (artesunate)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- artesunate
- Company
- Amivas Ireland Ltd
- Status
- Authorised
- Therapeutic area
- Malaria
- CHMP opinion
- Wed 16 Aug 2023
- EU approval
- Mon 22 Nov 2021
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005550
- ATC
- P01BE03
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Garsun Application withdrawn · B And O Pharm
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.