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Tolvaptan Accord

Active substance: tolvaptan

tolvaptan

Centralised EU authorisationActive

Marketing holder: Accord Healthcare S.L.U.

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 51
  • JYNARQUE
    TABLET · TOLVAPTAN 15 mg/1
    59148-082
    Otsuka America Pharmaceutical, Inc.
  • JYNARQUE
    TABLET · TOLVAPTAN 30 mg/1
    59148-083
    Otsuka America Pharmaceutical, Inc.
  • Jynarque
    KIT · tolvaptan
    59148-089
    Otsuka America Pharmaceutical, Inc.
  • Jynarque
    KIT · tolvaptan
    59148-088
    Otsuka America Pharmaceutical, Inc.
  • Jynarque
    KIT · tolvaptan
    59148-079
    Otsuka America Pharmaceutical, Inc.
All products in this country (51)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-2af0-7de4-b09b-dfd05bf74857,01a1208c-7f43-708f-8d33-fa90f50db9a7,01a1208c-83ec-78da-9fdd-0ed61e4e1328,01a1208c-a02b-7d2c-b876-80be9988368e,01a1208c-a053-70d4-8871-a494a4b81331;count=51 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005961
Registration status
Active
ATC code
C03XA01
Sources
  • product · EMA · EMEA/H/C/005961 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005961 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005961 · Verified 2026-10-09