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Drug
Brensocatib Monohydrate
Approved · EMA1
Regulatory events
Latest activity
betaRecent clinical, regulatory, research and industry developments relating to this drug.
Regulatory2025-11-18EMA
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Canonical name
Brensocatib Monohydrate
RxNorm CUI
2722771
Regulatory jurisdictions
ema
Regulatory timeline
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
2025-11-18
Latest approval
2025-11-18
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2025-11-18Approval
Approval: Brinsupri (EMA)
Indication: Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
Evidence ↗Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
References & data sources
- RxNorm (U.S. National Library of Medicine) — drug identity
- Regulatory event sources are credited in the Regulatory Timeline above.