Канада - французский - Health Canada

amgen canada inc - blinatumomab - poudre pour solution - 38.5mcg - blinatumomab 38.5mcg - antineoplastic agents

Европейский союз - французский - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - cellule précurseur leucémie lymphoblastique - lymphome - agents antinéoplasiques - blincyto is indicated 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. blincyto is indicated 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. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b 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 as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Швейцария - французский - Swissmedic (Swiss Agency for Therapeutic Products)

amgen switzerland ag - blinatumomabum - poudre pour solution à diluer pour perfusion - praeparatio cryodesiccata: blinatumomabum 38.5 µg, acidum citricum monohydricum, trehalosum dihydricum, lysini hydrochloridum, polysorbatum 80, natrii hydroxidum, pro vitro corresp. natrium 1.5 mg. solvens: acidum citricum monohydricum, lysini hydrochloridum, polysorbatum 80, natrii hydroxidum, aqua ad iniectabile q.s. ad solutionem pro 10 ml corresp. natrium 18.35 mg. - onkologikum - biotechnologika