Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1749753
Name of medicinal product: BESPONSA
Active substances:
Inotuzumab ozogamicin
Estonian, English, Latin
ATC code: L01FB01
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 1mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22- positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: April 21, 2022
Marketing authorization holder: Pfizer Europe MA EEIG 
Marketing authorization number: EU/1/17/1200 
Marketing authorization issued on: June 29, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 1, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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