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JINARC

30 + 60 Milligram Tablets

Otsuka Pharmaceutical Europe LtdEU/1/15/1000/008-010

Main Information

Trade NameJINARC
Active SubstancesTOLVAPTAN
Strength30 + 60 Milligram
Dosage FormTablets
Licence HolderOtsuka Pharmaceutical Europe Ltd
Licence NumberEU/1/15/1000/008-010

Group Information

ATC CodeC03XA01 tolvaptan

Status

Authorised/WithdrawnAuthorised
Licence Issued27/05/2015
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

Documents

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