🇪🇺 OPC-41061 in European Union

EMA authorised OPC-41061 on 27 May 2015

Marketing authorisations

EMA — authorised 27 May 2015

  • Application: EMEA/H/C/002788
  • Marketing authorisation holder: Otsuka Pharmaceutical Netherlands B.V.
  • Local brand name: Jinarc
  • Indication: Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.
  • Status: approved

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EMA — authorised 9 January 2026

  • Application: EMEA/H/C/005961
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Tolvaptan Accord
  • Indication: Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
  • Status: approved

The European Medicines Agency (EMA) approved Tolvaptan Accord (OPC-41061) for marketing in the European Union on 9 January 2026. This approval is for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH) in adults. Accord Healthcare S.L.U. is the marketing authorisation holder for Tolvaptan Accord.

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OPC-41061 in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is OPC-41061 approved in European Union?

Yes. EMA authorised it on 27 May 2015; EMA authorised it on 9 January 2026.

Who is the marketing authorisation holder for OPC-41061 in European Union?

Otsuka Pharmaceutical Netherlands B.V. holds the EU marketing authorisation.