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Secura Bio LimitedEU/1/21/1542/002

Main Information

Trade NameCopiktra
Active SubstancesDuvelisib
Dosage FormCapsule, hard
Licence HolderSecura Bio Limited
Licence NumberEU/1/21/1542/002

Group Information

ATC CodeL01EM04 Duvelisib


License statusAuthorised
Licence Issued19/05/2021
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown


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