Eiropas Savienība - latviešu - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - imūnsupresanti - 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

roche registration gmbh - tocilizumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; cytokine release syndrome; giant cell arteritis; covid-19 virus infection - imūnsupresanti - roactemra, kombinācijā ar metotreksātu (mtx), ir norādīts, forthe ārstēšana smagas, aktīva un progresējoša reimatoīdais artrīts (ra) pieaugušajiem, kas agrāk nav ārstēti ar mtx. ārstēšanā vidēji smagu vai smagu aktīvo ra pieaugušo pacientiem, kuriem ir vai nu atbildēja nepietiekami, lai vai kas bija, kas nepanes, iepriekšējā terapija ar vienu vai vairākām slimību modificējošiem pretreimatisma zāles (dmards) vai audzēja nekrozes faktora (tnf) antagonisti. Šiem pacientiem, roactemra var tikt dota monotherapy gadījumā mtx nepanesība vai kur turpināja ārstēšanu ar mtx nav piemērota. roactemra ir pierādīts, lai samazinātu likmi, locītavu bojājumu progresēšanu, mērot ar x-ray un uzlabot fizisko funkciju, ja to lieto kopā ar metotreksātu. roactemra ir indicēts, lai ārstētu aktīvo sistēmisko mazuļu idiopātisko artrītu (sjia) pacientiem līdz 1 gada vecumam un vecākiem, kuri atbildēja nepareizi uz iepriekšējo terapiju ar npl un sistēmiskos kortikosteroīdus. roactemra var tikt dota monotherapy (gadījumā, ja ir mtx nepanesība vai, ja ārstēšanu ar mtx nav piemērota) vai kombinācijā ar mtx. roactemra kombinācijā ar metotreksātu (mtx) ir indicēts, lai ārstētu nepilngadīgo idiopātiska poliartrīts (pjia; reimatoīdais faktors pozitīvs vai negatīvs, un pagarināt oligoarthritis) pacientiem 2 gadu vecuma un vecākiem, kuri ir atsaukušies nepietiekami, lai iepriekšējā terapija ar mtx. roactemra var tikt dota monotherapy gadījumā mtx nepanesība vai kur turpināja ārstēšanu ar mtx nav piemērota. roactemra ir indicēts, lai ārstētu milzu Šūnu arteritis (gca) pieaugušiem pacientiem. roactemra, kombinācijā ar metotreksātu (mtx), ir norādīts:ārstēšanai smagu, aktīvu un pakāpeniski reimatoīdais artrīts (ra) pieaugušajiem, kas agrāk nav ārstēti ar mtx. ārstēšanā vidēji smagu vai smagu aktīvo ra pieaugušo pacientiem, kuriem ir vai nu atbildēja nepietiekami, lai vai kas bija, kas nepanes, iepriekšējā terapija ar vienu vai vairākām slimību modificējošiem pretreimatisma zāles (dmards) vai audzēja nekrozes faktora (tnf) antagonisti. Šiem pacientiem, roactemra var tikt dota monotherapy gadījumā mtx nepanesība vai kur turpināja ārstēšanu ar mtx nav piemērota.  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 ir indicēts, lai ārstētu aktīvo sistēmisko mazuļu idiopātisko artrītu (sjia) pacientiem 2 gadu vecuma un vecākiem, kuri atbildēja nepareizi uz iepriekšējo terapiju ar npl un sistēmiskos kortikosteroīdus. roactemra var tikt dota monotherapy (gadījumā, ja ir mtx nepanesība vai, ja ārstēšanu ar mtx nav piemērota) vai kombinācijā ar mtx. roactemra kombinācijā ar metotreksātu (mtx) ir indicēts, lai ārstētu nepilngadīgo idiopātiska poliartrīts (pjia; reimatoīdais faktors pozitīvs vai negatīvs, un pagarināt oligoarthritis) pacientiem 2 gadu vecuma un vecākiem, kuri ir atsaukušies nepietiekami, lai iepriekšējā terapija ar mtx. roactemra var tikt dota monotherapy gadījumā mtx nepanesība vai kur turpināja ārstēšanu ar mtx nav piemērota. roactemra ir indicēts, lai ārstētu chimeric antigēnu receptori (auto) t šūnu izraisītas smagas vai dzīvībai bīstamas cytokine atbrīvot sindroms (drs) pieaugušajiem un pediatrijas pacientiem 2 gadu vecuma un vecāki. roactemra, kombinācijā ar metotreksātu (mtx), ir norādīts:ārstēšanai smagu, aktīvu un pakāpeniski reimatoīdais artrīts (ra) pieaugušajiem, kas agrāk nav ārstēti ar mtx. ārstēšanā vidēji smagu vai smagu aktīvo ra pieaugušo pacientiem, kuriem ir vai nu atbildēja nepietiekami, lai vai kas bija, kas nepanes, iepriekšējā terapija ar vienu vai vairākām slimību modificējošiem pretreimatisma zāles (dmards) vai audzēja nekrozes faktora (tnf) antagonisti. Šiem pacientiem, roactemra var tikt dota monotherapy gadījumā mtx nepanesība vai kur turpināja ārstēšanu ar mtx nav piemērota.  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 ir indicēts, lai ārstētu aktīvo sistēmisko mazuļu idiopātisko artrītu (sjia) pacientiem 2 gadu vecuma un vecākiem, kuri atbildēja nepareizi uz iepriekšējo terapiju ar npl un sistēmiskos kortikosteroīdus. roactemra var tikt dota monotherapy (gadījumā, ja ir mtx nepanesība vai, ja ārstēšanu ar mtx nav piemērota) vai kombinācijā ar mtx. roactemra kombinācijā ar metotreksātu (mtx) ir indicēts, lai ārstētu nepilngadīgo idiopātiska poliartrīts (pjia; reimatoīdais faktors pozitīvs vai negatīvs, un pagarināt oligoarthritis) pacientiem 2 gadu vecuma un vecākiem, kuri ir atsaukušies nepietiekami, lai iepriekšējā terapija ar mtx. roactemra var tikt dota monotherapy gadījumā mtx nepanesība vai kur turpināja ārstēšanu ar mtx nav piemērota. roactemra ir indicēts, lai ārstētu chimeric antigēnu receptori (auto) t šūnu izraisītas smagas vai dzīvībai bīstamas cytokine atbrīvot sindroms (drs) pieaugušajiem un pediatrijas pacientiem 2 gadu vecuma un vecāki.

Eiropas Savienība - latviešu - 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 - antineoplastiski līdzekļi - 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).

Eiropas Savienība - latviešu - 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 - antineoplastiski līdzekļi - 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - other antineoplastic agents - 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - multiple 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

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

Eiropas Savienība - latviešu - 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 - antineoplastiski līdzekļi - 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - limfoma, folikulāra - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - multiple mieloma - antineoplastiski līdzekļi - 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.