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BioCryst Ireland LtdEU/1/21/1544/001

Main Information

Trade NameOrladeyo
Active SubstancesBerotralstat hydrochloride
Dosage FormCapsule, hard
Licence HolderBioCryst Ireland Ltd
Licence NumberEU/1/21/1544/001

Group Information

ATC CodeB06AC06 berotralstat


License statusAuthorised
Licence Issued30/04/2021
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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