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Samsung Bioepis NL B.V.EU/1/16/1106/001

Main Information

Trade NameFlixabi
Active SubstancesInfliximab
Dosage FormPowder for concentrate for solution for infusion
Licence HolderSamsung Bioepis NL B.V.
Licence NumberEU/1/16/1106/001

Group Information

ATC CodeL04AB Tumor necrosis factor alpha (TNF-) inhibitors
L04AB02 infliximab


License statusAuthorised
Licence Issued26/05/2016
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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