Leukemia Myelogenous Chronic Bcr-abl Positive
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EMA approval · 2026-08-07EMA Authorised: Scemblix (asciminib hydrochloride) — Novartis Europharm Limited
EMA authorised Scemblix (asciminib hydrochloride) for chronic myeloid leukemia with BCR-ABL positive status.
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EMA approval · 2026-07-20EMA Authorised: Scemblix (asciminib hydrochloride) — Novartis Europharm Limited
Scemblix (asciminib hydrochloride) has been authorised in the EU for chronic myeloid leukemia positive for BCR-ABL, with orphan designation.
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EMA approval · 2025-05-06EMA Authorised: Imatinib Accord (imatinib) — Accord Healthcare S.L.U.
The EMA authorised Imatinib Accord (imatinib) for several indications, including Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dermatofibr…
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EMA withdrawal · 2023-10-19EMA Withdrawn: Imatinib Koanaa (imatinib mesilate) — Koanaa Healthcare GmbH
The EMA status shows Imatinib Koanaa (imatinib mesilate) has been withdrawn from the market by Koanaa Healthcare GmbH.
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EMA withdrawal · 2023-03-30EMA Withdrawn: Dasatinib Accord (dasatinib) — Accord Healthcare S.L.U.
The EMA has withdrawn the Dasatinib Accord product (dasatinib) from Accord Healthcare S.L.U., applicable to precursor cell lymphoblastic leu…
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EMA withdrawal · 2022-12-15EMA Withdrawn: IntronA (interferon alfa-2b) — Merck Sharp & Dohme B.V.
The European Medicines Agency has withdrawn IntronA (interferon alfa-2b) from the market.
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EMA withdrawal · 2019-10-16EMA Withdrawn: Imatinib medac (imatinib) — Medac
The EMA has withdrawn Imatinib Medac (imatinib) from the market.
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CLINICAL_TRIALS trial_result · 2018-11-14Clinical Trial Update: A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia [Phase 3]
Phase 3 trial comparing bosutinib to imatinib in newly diagnosed chronic phase CML; study completed with results posted in 2018.
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EMA withdrawal · 2018-10-09EMA Withdrawn: Imatinib Teva B.V. (imatinib mesilate) — Teva B.V.
EMA withdrew the Imatinib Teva B.V. product (imatinib mesilate) from the market.