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Drug

Bulevirtide acetate

Approved · EMA
RxNorm2607700
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Hepcludex (EMA)

Regulatory2020-07-31EMA

Profile

Identifiers & mechanism

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

Canonical name
Bulevirtide acetate
RxNorm CUI
2607700
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
2020-07-31
Latest approval
2020-07-31
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2020-07-31Approval
Approval: Hepcludex (EMA)
Indication: Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult and paediatric patients 3 years of age and… Show full indication

Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult and paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease.

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.