The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail


15 + 45 milligram(s) Tablet

Otsuka Pharmaceutical Netherlands B.V.EU/1/15/1000/005-007

Main Information

Trade NameJinarc
Active SubstancesTolvaptan
Strength15 + 45 milligram(s)
Dosage FormTablet
Licence HolderOtsuka Pharmaceutical Netherlands B.V.
Licence NumberEU/1/15/1000/005-007

Group Information

ATC CodeC03XA Vasopressin antagonists
C03XA01 tolvaptan


Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing Status


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back