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Pepaxti



Oncopeptides ABEU/1/22/1669/001

Main Information

Trade NamePepaxti
Active SubstancesMelphalan Flufenamide Hydrochloride
Dosage FormPowder for concentrate for solution for infusion
Licence HolderOncopeptides AB
Licence NumberEU/1/22/1669/001

Group Information

ATC CodeL01AA Nitrogen mustard analogues
L01AA10 Melphalan Flufenamide

Status

License statusAuthorised
Licence Issued17/08/2022
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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