Arikayce liposomal (amikacin)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- amikacin
- Company
- Insmed Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Respiratory Tract Infections
- CHMP opinion
- Thu 23 Jul 2020
- EU approval
- Tue 27 Oct 2020
- Designations
- Orphan
- Application
- EMEA/H/C/005264
- ATC
- J01GB06
- Official record
- www.ema.europa.eu
Indication
Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Arikayce Application withdrawn · Insmed Limited
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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.