Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1806780
Name of medicinal product: BORTEZOMIB FRESENIUS KABI
Active substances:
Bortezomib
Estonian, English, Latin
ATC code: L01XG01
Dosage form: powder for solution for injection
Route of administration: intravenous use; subcutaneous use
Strengh: 3,5mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: May 2, 2024
Marketing authorization holder: Fresenius Kabi Deutschland GmbH 
Marketing authorization number: EU/1/19/1397 
Marketing authorization issued on: November 14, 2019 
Marketing authorization expires on: November 18, 2024 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: December 9, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere