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Ocaliva

5 milligram(s) Tablet

Intercept Pharma LtdEU/1/16/1139/001

Main Information

Trade NameOcaliva
Active SubstancesObeticholic acid
Strength5 milligram(s)
Dosage FormTablet
Licence HolderIntercept Pharma Ltd
Licence NumberEU/1/16/1139/001

Group Information

ATC CodeA05AA Bile acid preparations
A05AA04 Obeticholic Acid

Status

Authorised/WithdrawnAuthorised
Licence Issued
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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