Dasatinib Accord Healthcare (dasatinib)
- Region
- 🇪🇺 EU
- Active substance
- dasatinib
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- CHMP opinion
- Thu 30 May 2024
- EU approval
- Fri 26 Jul 2024
- Designations
- Generic
- Application
- EMEA/H/C/006251
- ATC
- L01EA02
- Official record
- www.ema.europa.eu
Indication
Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Dasatinib Accord Healthcare is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Sprycel Authorised · Bristol-Myers Squibb Pharma EEIG
- 🇪🇺 Dasatinib Accord Withdrawn · Accord Healthcare S.L.U.
- 🇪🇺 Dasatinib Accordpharma Withdrawn · Accord Healthcare S.L.U.
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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.