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Bekemv



Amgen Technology (Ireland) UCEU/1/23/1727/001

Main Information

Trade NameBekemv
Active SubstancesEculizumab
Dosage FormConcentrate for solution for infusion
Licence HolderAmgen Technology (Ireland) UC
Licence NumberEU/1/23/1727/001

Group Information

ATC CodeL04AA25 eculizumab

Status

License statusAuthorised
Licence Issued19/04/2023
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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