Atriance (nelarabine)
- Region
- 🇪🇺 EU
- Active substance
- nelarabine
- Company
- Sandoz Pharmaceuticals d.d.
- Status
- Authorised
- Therapeutic area
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
- EU approval
- Wed 22 Aug 2007
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/000752
- ATC
- L01BB07
- Official record
- www.ema.europa.eu
Indication
Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Regulatory milestones
No milestones recorded in the last year.
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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.