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Samsung Bioepis NL B.V.EU/1/17/1216/005-008

Main Information

Trade NameImraldi
Active SubstancesAdalimumab
Dosage FormSolution for injection in pre-filled pen
Licence HolderSamsung Bioepis NL B.V.
Licence NumberEU/1/17/1216/005-008

Group Information

ATC CodeL04AB04 adalimumab


License statusAuthorised
Licence Issued
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

Educational Materials - Patient

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