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BESPONSA 1 mg powder for concentrate for solution for infusion



Pfizer Europe MA EEIGEU/1/17/1200/001

Main Information

Trade NameBESPONSA 1 mg powder for concentrate for solution for infusion
Active SubstancesInotuzumab ozogamicin
Dosage FormPowder for concentrate for solution for infusion
Licence HolderPfizer Europe MA EEIG
Licence NumberEU/1/17/1200/001

Group Information

ATC CodeL01XC26 Inotuzumab Ozogamicin

Status

License statusAuthorised
Licence Issued29/06/2017
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 StatusMarketed

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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