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Kepivance

Active substance: palifermin

palifermin

Centralised EU authorisationWithdrawn

Marketing holder: Swedish Orphan Biovitrum AB (publ)

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
  • KEPIVANCE
    INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · PALIFERMIN 5.16 mg/1.2mL
    66658-113
    Swedish Orphan Biovitrum AB (publ)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12096-eb6c-7681-9820-1f3bd67bd0ad;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000609
Registration status
Withdrawn
ATC code
V03AF08
Sources
  • product · EMA · EMEA/H/C/000609 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000609 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000609 · Verified 2026-10-09