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SMC ID Date Medicine Submission Type Indication
SMC2808 08/09/2025 blinatumomab (Blincyto) Full

Treatment of adult patients with Philadelphia chromosome (Ph)-negative, CD19-positive, B-cell precursor acute lymphoblastic leukaemia (ALL) in the consolidation phase.

SMC2468 07/03/2022 blinatumomab (Blincyto) Non submission

As monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.

SMC2234 09/03/2020 blinatumomab (Blincyto) Full

As monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

SMC2148 08/04/2019 blinatumomab (Blincyto) Abbreviated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation
1145/16 13/06/2016 blinatumomab (Blincyto) Full the treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).

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