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Padcev



Astellas Pharma Europe B.V.EU/1/21/1615/002

Main Information

Trade NamePadcev
Active SubstancesEnfortumab Vedotin
Dosage FormPowder for concentrate for solution for infusion
Licence HolderAstellas Pharma Europe B.V.
Licence NumberEU/1/21/1615/002

Group Information

ATC CodeL01 ANTINEOPLASTIC AGENTS
L01FX13 enfortumab vedotin

Status

License statusAuthorised
Licence Issued13/04/2022
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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