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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1887295
Name of medicinal product: BORTEZOMIB STADA
Active substances:
Bortezomib
Estonian, English, Latin
ATC code: L01XG01
Dosage form: solution for injection
Route of administration: intravenous use; subcutaneous use
Strengh: 2,5mg 1ml
Amount in package: 2.8ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: 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. 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. 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. 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):  (last updated June 30, 2023)
Package information leaflet (PIL): EST  (last updated June 30, 2023)
Labelling:  (last updated July 7, 2022)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Stada Arzneimittel AG 
Marketing authorization number: 1026421 
Marketing authorization issued on: March 31, 2021 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 16, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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