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Samsca



Otsuka Pharmaceutical Netherlands B.V.EU/1/09/539/3-4

Main Information

Trade NameSamsca
Active SubstancesTolvaptan
Dosage FormTablet
Licence HolderOtsuka Pharmaceutical Netherlands B.V.
Licence NumberEU/1/09/539/3-4

Group Information

ATC CodeC03XA Vasopressin antagonists
C03XA01 tolvaptan

Status

License statusAuthorised
Licence Issued03/08/2009
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

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