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KEPIVANCE

Active substance: palifermin

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · PALIFERMIN 5.16 mg/1.2mL

United StatesActive

Marketing holder: Swedish Orphan Biovitrum AB (publ)

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 1
  • Kepivance
    palifermin
    EMEA/H/C/000609
    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
66658-113
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 66658-113 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 66658-113 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 66658-113 · Verified 2026-10-09 · open in source