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Hepcludex

Active substance: bulevirtide

bulevirtide acetate

Centralised EU authorisationActive

Marketing holder: Gilead Sciences Ireland UC

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 1
  • HEPCLUDEX
    INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · BULEVIRTIDE ACETATE 8.5 mg/1
    61958-3104
    Gilead Sciences, Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-971b-72b1-8a31-15c2d46fed06;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004854
Registration status
Active
ATC code
J05A
Sources
  • product · EMA · EMEA/H/C/004854 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004854 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004854 · Verified 2026-10-09