Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan ireland limited - lenalidomide - multiple mieloma - imūnsupresanti - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - imūnsupresanti - multiple myelomalenalidomide krka d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) ir norādīts ārstēšanai pieaugušiem pacientiem ar iepriekš neārstētiem multiplā mieloma, kas nav tiesīgi transplantātu. lenalidomide krka d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - antineoplastiski līdzekļi - 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).

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)

oncopeptides ab - melphalan flufenamide hydrochloride - multiple mieloma - antineoplastiski līdzekļi - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

dendreon uk ltd - autologās perifēro asiņu monocikliski šūnām, ieskaitot vismaz 50 miljoni autologās cd54 + šūnu aktivizē ar prostatic acid kinase granulocyte-makrofāgu koloniju stimulējot faktors - prostatas audzēji - other immunostimulants - provenge ir indicēts bez simptomiem vai minimāli simptomātiska metastātisku (bez viscerālu) kastrēt rezistentiem prostatas vēža ārstēšanai vīriešu pieaugušajiem, kuriem ķīmijterapija nav vēl klīniski norādīts.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - other nervous system drugs - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumabs - multiple mieloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. kopā ar bortezomib, talidomīds un deksametazona ārstēšanai pieaugušiem pacientiem, kuriem nesen diagnosticēta multiplā mieloma, kuri ir tiesīgi saņemt autologās cilmes šūnu transplantācijas. kopā ar lenalidomide un deksametazona, vai bortezomib un deksametazona, ārstēšanai pieaugušiem pacientiem ar multiplā mieloma, kuri ir saņēmuši vismaz vienu pirms terapijas. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. kā monotherapy ārstēšanai pieaugušiem pacientiem ar relapsed un ugunsizturīgo multiplā mieloma, kuru pirms terapijas iekļauts proteasome inhibitoru un imūnmodulējošu līdzekli un kas ir pierādījuši slimības progresēšanu pēdējā terapija. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

roche registration gmbh - epoetīns beta - kidney failure, chronic; anemia; cancer; blood transfusion, autologous - antianēmiski līdzekļi - Ārstēšana simptomātiska anēmija, kas saistīta ar hronisku nieru mazspēju (crf), pieaugušajiem un pediatrijas pacientiem;ārstēšana simptomātisku anēmiju, pieaugušiem pacientiem ar ne-mieloīdu ļaundabīgu audzēju, kas saņem ķīmijterapiju;palielinot ienesīgumu, autologās asinis no pacientiem pirms ziedošanas programmu. tās izmantošana šajā norāde ir jāsamēro ziņots, palielināts risks saslimt ar trombembolisku notikumu. Ārstēšana ir tikai jāpievērš pacientiem ar mērenu anēmiju (hb 10 - 13 g/dl [6. 21 - 8. 07 mmol/l], nav dzelzs deficīts), ja asins saglabāšanas procedūras nav vai tās nav pietiekamas, kad ieplānoto galveno plānveida operāciju nepieciešams liels asins apjoms (4 vai vairāk vienības asiņu, sievietēm vai 5 vai vairāk vienībām, par vīriešiem).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - lenalidomide - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - imūnsupresanti - vairākas myelomarevlimid kā monotherapy ir norādīts tehniskās apkopes ārstēšanai pieaugušiem pacientiem, kuriem nesen diagnosticēta multiplā mieloma, kam ir veikta autologo cilmes šūnu transplantācijas. revlimid kā kombinēto terapiju ar deksametazona, vai bortezomib un deksametazona, vai melfalānu un prednizonu (skatīt 4. iedaļu. 2) ir norādīts ārstēšanai pieaugušiem pacientiem ar iepriekš neārstētiem multiplā mieloma, kas nav tiesīgi transplantātu. revlimid kopā ar deksametazona ir indicēts, lai ārstētu multiplā mieloma pieaugušo pacientiem, kuri ir saņēmuši vismaz vienu pirms terapijas. mielodisplastiskais syndromesrevlimid kā monotherapy ir norādīts ārstēšanai pieaugušiem pacientiem ar asins pārliešanu atkarīgas no anēmijas dēļ zemas vai vidējas-1-riska mielodisplastiskais sindromi, kas saistīti ar atsevišķu dzēšanu 5q cytogenetic anomālija, kad citi terapijas iespējas ir nepietiekamas vai neatbilstošas. apmetņa šūnu lymphomarevlimid kā monotherapy ir norādīts ārstēšanai pieaugušiem pacientiem ar relapsed vai ugunsizturīgu apvalku šūnu limfomas. folikulu lymphomarevlimid kopā ar rituksimaba (anti-cd20 antivielu) ir norādīts ārstēšanai pieaugušiem pacientiem ar iepriekš apstrādāts folikulu limfomas (1. pakāpe – 3a).