Europeiska unionen - svenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - antineoplastiska medel - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Europeiska unionen - svenska - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - lymfom, mantelcell - antineoplastiska medel - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Europeiska unionen - svenska - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastiska medel - rituzena är indicerat hos vuxna för följande indikationer:non-hodgkins lymfom (nhl)rituzena är indicerat för behandling av tidigare obehandlade patienter med stadium iii-iv follikulära lymfom i kombination med kemoterapi. rituzena monoterapi är indicerat för behandling av patienter med stadium iii-iv follikulära lymfom som är resistenta mot cellgifter eller är i sitt andra eller efterföljande återfall efter kemoterapi. rituzena är indicerat för behandling av patienter med cd20-positiva diffusa stora b-cells non hodgkins lymfom i kombination med chop (cyklofosfamid, doxorubicin, vinkristin, prednisolon) kemoterapi. kronisk lymfatisk leukemi (kll)rituzena i kombination med kemoterapi är indicerat för behandling av patienter med tidigare obehandlat och återfall/refraktär kll. endast begränsade data finns tillgängliga om effekten och säkerheten för patienter som tidigare behandlats med monoklonala antikroppar inklusive rituzenaor patienter med refraktära mot tidigare rituzena plus kemoterapi. granulomatos med polyangit och mikroskopiska polyangiitisrituzena, i kombination med glukokortikoider, är indicerat för induktion av remission hos vuxna patienter med svår, aktiv granulomatos med polyangit (wegeners) (gpa) och mikroskopisk polyangit (mpa).

Europeiska unionen - svenska - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - prekursorcell lymfoblastisk leukemi-lymfom - antineoplastiska medel - 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - andra antineoplastiska medel - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

Europeiska unionen - svenska - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - antineoplastiska medel - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Europeiska unionen - svenska - EMA (European Medicines Agency)

swedish orphan biovitrum ab - loncastuximab tesirine - lymphoma, large b-cell, diffuse; lymphoma, b-cell - antineoplastiska medel - zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl), after two or more lines of systemic therapy.

Europeiska unionen - svenska - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - antineoplastiska medel - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

Europeiska unionen - svenska - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunsuppressiva - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Europeiska unionen - svenska - EMA (European Medicines Agency)

fondazione telethon ets - autologa cd34 + berikad cell fraktion som innehåller cd34 + celler sensorik med retrovirala vektor som kodar för humant adenosin adenosinedeaminase (ada) cdna sekvensen från mänskliga hematopoetiska stamceller / (cd34 +) stamceller - svår kombinerad immunbrist - immunstimulatorer, - strimvelis är indicerat för behandling av patienter med svår kombinerad immunbrist på grund av adenosin adenosinedeaminase brist (ada-scid), för vilka ingen lämplig humant leukocytantigen (hla)-matchade relaterade stamceller donatorn är tillgängliga (se avsnitt 4. 2 och 4.