Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1653296
Name of medicinal product: BENDAMUSTINE MEDAC
Active substances:
Bendamustine
Estonian, English, Latin
ATC code: L01AA09
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 2,5mg 1ml
Amount in package: 25mg 5TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. Indolent non-Hodgkin's lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen. Front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated November 28, 2023)
Package information leaflet (PIL): EST  (last updated November 28, 2023)
Labelling:  (last updated August 23, 2018)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Medac Gesellschaft für klinische Spezialpräparate mbH 
Marketing authorization number: 874115 
Marketing authorization issued on: July 2, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 28, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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