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Advanz Pharma LimitedEU/1/16/1139/002

Main Information

Trade NameOcaliva
Active SubstancesObeticholic acid
Dosage FormFilm-coated tablet
Licence HolderAdvanz Pharma Limited
Licence NumberEU/1/16/1139/002

Group Information

ATC CodeA05AA Bile acid preparations
A05AA04 Obeticholic Acid


License statusAuthorised
Licence Issued12/12/2016
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


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