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BESPONSA

1 Milligram Pdr/Conc/Soln for Infus

Pfizer LimitedEU/1/17/1200/001

Main Information

Trade NameBESPONSA
Active SubstancesINOTUZUMAB OZOGAMICIN
Strength1 Milligram
Dosage FormPdr/Conc/Soln for Infus
Licence HolderPfizer Limited
Licence NumberEU/1/17/1200/001

Group Information

ATC CodeL01XC26 Inotuzumab Ozogamicin

Status

Authorised/WithdrawnAuthorised
Licence Issued29/06/2017
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing StatusMarketed
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

Documents

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