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Gevalka

Active substance: ensartinib

ensartinib dihydrochloride

Centralised EU authorisationActive

Marketing holder: SFL Pharmaceuticals Deutschland GmbH

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 2
  • ENSACOVE
    CAPSULE · ENSARTINIB HYDROCHLORIDE 100 mg/1
    83076-1100
    Xcovery Holdings, Inc.
  • ENSACOVE
    CAPSULE · ENSARTINIB HYDROCHLORIDE 25 mg/1
    83076-1025
    Xcovery Holdings, Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1209a-4a21-798c-aa6a-2911ad9f00f2,01a1209c-6d08-7cf8-9744-28fb9326e644;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/006757
Registration status
Active
Sources
  • product · EMA · EMEA/H/C/006757 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/006757 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/006757 · Verified 2026-10-09