Nilotinib Accord (nilotinib)
- Region
- 🇪🇺 EU
- Active substance
- nilotinib
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- CHMP opinion
- Thu 27 Jun 2024
- EU approval
- Thu 22 Aug 2024
- Designations
- Generic
- Application
- EMEA/H/C/006315
- ATC
- L01EA03
- Official record
- www.ema.europa.eu
Indication
Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇺🇸 Cavhanza Approved · Cycle
- 🇪🇺 Tasigna Authorised · Novartis Europharm Limited
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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.