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Drug

Amikacin sulfate

Approved · EMA
Early-to-mid development

Also known as Amikin, Amikacin sulphate, amikacin (as sulfate).

1
Regulatory events

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Amikacin sulfate
Aliases & brands
AmikinAmikacin sulphateamikacin (as sulfate)
RxNorm CUI
643
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2020-10-27
Latest approval
2020-10-27
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2020-10-27Approval
Approval: Arikayce liposomal (EMA)
Indication: Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limitedShow full 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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

2 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
2
registered trials across all phases
LATEST COMPLETION 1998
1
Late-stage (III+)
2
Completed
PHASE DISTRIBUTIONn = 2
Phase 21Phase N / A1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.