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Copiktra



Secura Bio LimitedEU/1/21/1542/001

Main Information

Trade NameCopiktra
Active SubstancesDuvelisib
Dosage FormCapsule, hard
Licence HolderSecura Bio Limited
Licence NumberEU/1/21/1542/001

Group Information

ATC CodeL01 ANTINEOPLASTIC AGENTS
L01EM04 Duvelisib

Status

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

Documents

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