Bortezomib Fresenius Kabi (bortezomib)
- Region
- 🇪🇺 EU
- Active substance
- bortezomib
- Company
- Fresenius Kabi Deutschland GmbH
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 19 Sep 2019
- EU approval
- Thu 14 Nov 2019
- Designations
- Generic
- Application
- EMEA/H/C/005074
- ATC
- L01XG01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Bortezomib Hospira Withdrawn · Pfizer Europe MA EEIG
- 🇪🇺 Bortezomib Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Bortezomib Sun Authorised · SUN Pharmaceutical Industries (Europe) B.V.
- 🇪🇺 Velcade Authorised · Janssen-Cilag International NV
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.