Arikayce (amikacin sulfate)
- Region
- 🇪🇺 EU
- Active substance
- amikacin sulfate
- Company
- Insmed Limited
- Status
- Application withdrawn
- Therapeutic area
- Mycobacterium Infections
- Application
- EMEA/H/C/003936
- ATC
- J01GB06
- Official record
- www.ema.europa.eu
Indication
Arikayce is indicated for: treatment of Mycobacterium avium Complex (MAC) lung disease in adult patients who have persistent positive sputum cultures despite the use of medically appropriate first-line therapy Consideration should be given to official guidance on the appropriate use of antibacterial agents. Arikayce should be added to existing therapy and should not be used as monotherapy.
Regulatory milestones
No milestones recorded in the last year.
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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.