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Amgevita



Amgen Europe B.V.EU/1/16/1164/017-019

Main Information

Trade NameAmgevita
Active SubstancesAdalimumab
Dosage FormSolution for injection in pre-filled syringe
Licence HolderAmgen Europe B.V.
Licence NumberEU/1/16/1164/017-019

Group Information

ATC CodeL04AB04 adalimumab

Status

License statusAuthorised
Licence Issued16/05/2024
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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