Bortezomib Sun (bortezomib)
- Region
- 🇪🇺 EU
- Active substance
- bortezomib
- Company
- SUN Pharmaceutical Industries (Europe) B.V.
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Sat 26 Mar 2016
- EU approval
- Fri 22 Jul 2016
- Designations
- Generic
- Application
- EMEA/H/C/004076
- ATC
- L01XG01
- Official record
- www.ema.europa.eu
Indication
Bortezomib SUN 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 SUN 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 SUN 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 SUN 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- 🇪🇺 Bortezomib Hospira Withdrawn · Pfizer Europe MA EEIG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 Fresenius Kabi Authorised · Fresenius Kabi Deutschland GmbH
- 🇪🇺 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.