Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: BENDAMUSTINE BOSTON BIOPHARMA
Active substances:
Bendamustine
Estonian, English, Latin
ATC code: L01AA09
Dosage form: powder for concentrate for solution for infusion
Strength: 2,5mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated September 5, 2022)
Package information leaflet (PIL): EST  (last updated September 5, 2022)
Labelling:  (last updated September 5, 2022)
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
Marketing authorization holder: Boston Biopharma LT UAB 
Marketing authorization number: 1070222 
Marketing authorization issued on: September 5, 2022 
Marketing authorization expires on: September 5, 2027 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1835816  BENDAMUSTINE BOSTON BIOPHARMA  powder for concentrate for solution for infusion  2,5mg 1ml 25mg 1TK  Prescription           
1835827  BENDAMUSTINE BOSTON BIOPHARMA  powder for concentrate for solution for infusion  2,5mg 1ml 100mg 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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