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Active substance: saxagliptin, dapagliflozin propanediol monohydrate

saxagliptin, dapagliflozin propanediol monohydrate

Centralised EU authorisationActive

Marketing holder: Astra Zeneca AB

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Products containing saxagliptin in other countries

Showing products with this active substance, combinations included; the full composition is shown for each product.

CountryProducts
US 13
  • DAPAGLIFLOZIN AND SAXAGLIPTIN
    TABLET, FILM COATED · DAPAGLIFLOZIN 10 mg/1, SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE 5 mg/1
    72205-438
    Novadoz Pharmaceuticals LLC
  • SAXAGLIPTIN
    TABLET, FILM COATED · SAXAGLIPTIN HYDROCHLORIDE 2.5 mg/1
    68462-726
    Glenmark Pharmaceuticals Inc., USA
  • SAXAGLIPTIN
    TABLET, FILM COATED · SAXAGLIPTIN HYDROCHLORIDE 5 mg/1
    68462-727
    Glenmark Pharmaceuticals Inc., USA
  • Saxagliptin
    TABLET, FILM COATED · SAXAGLIPTIN HYDROCHLORIDE 5 mg/1
    65862-826
    Aurobindo Pharma Limited
  • Saxagliptin
    TABLET, FILM COATED · SAXAGLIPTIN HYDROCHLORIDE 2.5 mg/1
    65862-825
    Aurobindo Pharma Limited
All products in this country (13)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-9b07-7485-88a6-39cdc496882c,01a1208d-8ef9-74ee-b614-1b580c27a043,01a12092-6276-7587-be0c-bba529dc7012,01a12094-4017-70f9-9525-48e547fc882b,01a12097-0e9a-7e71-8738-a1b04d523179;count=6 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004057
Registration status
Active
ATC code
A10BD21
Sources
  • product · EMA · EMEA/H/C/004057 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004057 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004057 · Verified 2026-10-09
  • ingredients.1 · EMA · EMEA/H/C/004057 · Verified 2026-10-09