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Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma)

Active substance: dabigatran etexilate

dabigatran etexilate mesilate

Centralised EU authorisationActive

Marketing holder: Teva 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 50
  • DABIGATRAN
    CAPSULE · DABIGATRAN ETEXILATE MESYLATE 150 mg/1
    50090-7530
    A-S Medication Solutions
  • DABIGATRAN
    CAPSULE · DABIGATRAN ETEXILATE MESYLATE 75 mg/1
    50090-7531
    A-S Medication Solutions
  • DABIGATRAN
    CAPSULE · DABIGATRAN ETEXILATE MESYLATE 110 mg/1
    72205-203
    Novadoz Pharmaceuticals LLC
  • DABIGATRAN
    CAPSULE · DABIGATRAN ETEXILATE MESYLATE 75 mg/1
    72205-202
    Novadoz Pharmaceuticals LLC
  • DABIGATRAN
    CAPSULE · DABIGATRAN ETEXILATE MESYLATE 75 mg/1
    42291-033
    AvKARE
All products in this country (50)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-2d64-7d1c-98a9-93016b4378d5,01a1208c-32a6-7dce-b827-f878ec065dcf,01a1208c-32a9-71f9-a326-ccffd4b9482b,01a1208c-449e-7020-b866-85c48467118b,01a1208c-5e11-76b7-936b-dc6116ba9016;count=50 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005922
Registration status
Active
ATC code
B01AE07
Sources
  • product · EMA · EMEA/H/C/005922 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005922 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005922 · Verified 2026-10-09