Detailed SMPC and OD register data for: BLINCYTO
Data as extracted from Orphan Designation Register
Product (OD)
BLINCYTO
PL number (OD)
PLGB 13832/0018
OD Designation ID (OD)
OD1
Active substance (OD)
Blinatumomab
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
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Further information for:
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OD Indication (OD)
BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. BLINCYTO is indicated 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 haematopoietic stem cell transplantation. BLINCYTO is indicated for the treatment of adult patients with Philadelphia chromosome negative CD19-positive B-cell precursor leukaemia ALL in the consolidation phase. BLINCYTO is indicated for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19-positive B-cell precursor leukaemia ALL in first relapse in the consolidation phase.
Full Designation Number(OD)
PLGB 13832/0018/OD1
Orphan Condition(OD)
Acute lymphoblastic leukaemia
All Indications (SMPC)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
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