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Balversa

Active substance: erdafitinib

Erdafitinib

Centralised EU authorisationActive

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 3
  • BALVERSA
    TABLET, FILM COATED · ERDAFITINIB 3 mg/1
    59676-030
    Janssen Products LP
  • BALVERSA
    TABLET, FILM COATED · ERDAFITINIB 4 mg/1
    59676-040
    Janssen Products LP
  • BALVERSA
    TABLET, FILM COATED · ERDAFITINIB 5 mg/1
    59676-050
    Janssen Products LP
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-5295-7af9-8b14-09a4f021401a,01a12093-e2b7-7a44-ae8e-5464e768df21,01a1209d-a2d3-7687-938b-3c5fd6da7a7a;count=3 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/006050
Registration status
Active
ATC code
L01EN01
Sources
  • product · EMA · EMEA/H/C/006050 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/006050 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/006050 · Verified 2026-10-09