Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumabas - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - imunosupresantai - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

roche registration gmbh - tocilizumabas - arthritis, rheumatoid; arthritis, juvenile rheumatoid; cytokine release syndrome; giant cell arteritis; covid-19 virus infection - imunosupresantai - roactemra, kartu su metotreksatas (mtx), yra nurodyta forthe gydymas sunkus, aktyvus ir palaipsniui reumatoidiniu artritu (ra), suaugusiems ne anksčiau elgiamasi su mtx. gydymo nuo vidutinio iki sunkaus aktyvaus ra suaugusiųjų pacientų, kurie turi atsakė netinkamai, arba kurie buvo netoleruoja, ankstesnių terapija su viena ar daugiau ligų-pakeisti anti-reumato narkotikų (dmards) arba naviko nekrozės faktorius (tnf) antagonistai. Šiems pacientams, roactemra gali būti suteikiamas kaip monotherapy atveju nepakantumas mtx arba kai tolesnis gydymas su mtx netinka. roactemra buvo įrodyta, kad sumažinti greitį progresavimą, bendrą žalą, vertinant pagal x-ray ir gerinti fizinę funkciją, skiriant kartu su metotreksatu. roactemra fluorouracilu ir folino aktyvių sisteminės jaunatvinis idiopatinis artritas (sjia) pacientams, 1 metų amžiaus ir vyresni, kurie reagavo netinkamai ankstesnių terapija su nvnu ir sisteminio kortikosteroidų. roactemra gali būti suteikiamas kaip monotherapy (jei nepakantumas mtx arba kai gydymas, mtx, yra netinkamas) ar kartu su mtx. roactemra kartu su metotreksatas (mtx) yra nurodyta gydymo jaunatvinis idiopatinis poliartritas (pjia; reumatoidinis faktorius teigiamas arba neigiamas ir pratęsti oligoarthritis) pacientams, kuriems 2 metų amžiaus ir vyresni, kurie reagavo netinkamai ankstesnių terapija su mtx. roactemra gali būti suteikiamas kaip monotherapy atveju nepakantumas mtx arba kai tolesnis gydymas su mtx netinka. roactemra fluorouracilu ir folino milžinišką ląstelių arterito (gca) suaugusių pacientų. roactemra, kartu su metotreksatas (mtx), yra nurodyta:gydymas sunkus, aktyvus ir palaipsniui reumatoidiniu artritu (ra), suaugusiems ne anksčiau elgiamasi su mtx. gydymo nuo vidutinio iki sunkaus aktyvaus ra suaugusiųjų pacientų, kurie turi atsakė netinkamai, arba kurie buvo netoleruoja, ankstesnių terapija su viena ar daugiau ligų-pakeisti anti-reumato narkotikų (dmards) arba naviko nekrozės faktorius (tnf) antagonistai. Šiems pacientams, roactemra gali būti suteikiamas kaip monotherapy atveju nepakantumas mtx arba kai tolesnis gydymas su mtx netinka.  roactemra has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. roactemra is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. roactemra fluorouracilu ir folino aktyvių sisteminės jaunatvinis idiopatinis artritas (sjia) pacientams, kuriems 2 metų amžiaus ir vyresni, kurie reagavo netinkamai ankstesnių terapija su nvnu ir sisteminio kortikosteroidų. roactemra gali būti suteikiamas kaip monotherapy (jei nepakantumas mtx arba kai gydymas, mtx, yra netinkamas) ar kartu su mtx. roactemra kartu su metotreksatas (mtx) yra nurodyta gydymo jaunatvinis idiopatinis poliartritas (pjia; reumatoidinis faktorius teigiamas arba neigiamas ir pratęsti oligoarthritis) pacientams, kuriems 2 metų amžiaus ir vyresni, kurie reagavo netinkamai ankstesnių terapija su mtx. roactemra gali būti suteikiamas kaip monotherapy atveju nepakantumas mtx arba kai tolesnis gydymas su mtx netinka. roactemra nurodomas gydymo chimeric antigenų receptorių (car), t ląstelių sukeltas sunkus arba gyvybei citokinų išsiskyrimą sindromo (crs) suaugusiems ir pediatrinių pacientų 2 metų amžiaus ir vyresni. roactemra, kartu su metotreksatas (mtx), yra nurodyta:gydymas sunkus, aktyvus ir palaipsniui reumatoidiniu artritu (ra), suaugusiems ne anksčiau elgiamasi su mtx. gydymo nuo vidutinio iki sunkaus aktyvaus ra suaugusiųjų pacientų, kurie turi atsakė netinkamai, arba kurie buvo netoleruoja, ankstesnių terapija su viena ar daugiau ligų-pakeisti anti-reumato narkotikų (dmards) arba naviko nekrozės faktorius (tnf) antagonistai. Šiems pacientams, roactemra gali būti suteikiamas kaip monotherapy atveju nepakantumas mtx arba kai tolesnis gydymas su mtx netinka.  roactemra has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. roactemra is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. roactemra fluorouracilu ir folino aktyvių sisteminės jaunatvinis idiopatinis artritas (sjia) pacientams, kuriems 2 metų amžiaus ir vyresni, kurie reagavo netinkamai ankstesnių terapija su nvnu ir sisteminio kortikosteroidų. roactemra gali būti suteikiamas kaip monotherapy (jei nepakantumas mtx arba kai gydymas, mtx, yra netinkamas) ar kartu su mtx. roactemra kartu su metotreksatas (mtx) yra nurodyta gydymo jaunatvinis idiopatinis poliartritas (pjia; reumatoidinis faktorius teigiamas arba neigiamas ir pratęsti oligoarthritis) pacientams, kuriems 2 metų amžiaus ir vyresni, kurie reagavo netinkamai ankstesnių terapija su mtx. roactemra gali būti suteikiamas kaip monotherapy atveju nepakantumas mtx arba kai tolesnis gydymas su mtx netinka. roactemra nurodomas gydymo chimeric antigenų receptorių (car), t ląstelių sukeltas sunkus arba gyvybei citokinų išsiskyrimą sindromo (crs) suaugusiems ir pediatrinių pacientų 2 metų amžiaus ir vyresni.

Europos Sąjunga - lietuvių - 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) - limfoma, mantle-cell - antinavikiniai vaistai - 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).

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - antinavikiniai vaistai - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - daugybinė mieloma - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - idecabtagene vicleucel - multiple myeloma; neoplasms; cancer; neoplasms, plasma cell; hemostatic disorders; vascular diseases; cardiovascular diseases; paraproteinemias; blood protein disorders; hematologic diseases; hemic and lymphatic diseases; hemorrhagic disorders; infectious mononucleosis; lymphoproliferative disorders; immunoproliferative disorders; immune system diseases - antinavikiniai vaistai - abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - kiti antineoplastiniai agentai - 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.

Europos Sąjunga - lietuvių - 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 - antinavikiniai vaistai - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - antinavikiniai vaistai - columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl), after two or more lines of systemic therapy.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - daugybinė mieloma - antinavikiniai vaistai - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.