Euroopa Liit - eesti - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - antineoplastilised ained - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris on näidustatud ravi täiskasvanud patsientidel, kellel on taastekkinud või tulekindlad cd30+ hodgkini lümfoom (hl):pärast asct, orfollowing vähemalt kaks enne ravi kui asct või multi-agent keemiaravi ei ole ravi valik. süsteemne anaplastic suur kärje lymphomaadcetris koos tsüklofosfamiidi, doxorubicin ja prednisoon (chp) on näidustatud täiskasvanud patsientidel, kellel on varem ravimata süsteemne anaplastic suur raku lümfoom (salcl). adcetris on näidustatud ravi täiskasvanud patsientidel, kellel on taastekkinud või tulekindlad salcl. naha t-rakkude lymphomaadcetris on näidustatud ravi täiskasvanud patsientidel, kellel cd30+ naha t-raku lümfoom (ctcl) pärast vähemalt 1 enne süsteemset ravi.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastilised ained - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

recordati netherlands b.v. - dinutuximab beta - neuroblastoom - antineoplastilised ained - qarziba on näidustatud ravi kõrge riskiga neuroblastoma patsientidel vanuses 12 kuud ja rohkem, kes on eelnevalt saanud induktsioon kemoteraapia ja saavutada vähemalt osalise vastuse, millele järgneb myeloablative ravi ja tüvirakkude siirdamine, ning samuti patsientidel, kellel on anamneesis taastekkinud või tulekindlad neuroblastoma, koos või ilma järelejäänud haigus. enne retsidiveerunud neuroblastoomi ravimist tuleks mis tahes aktiivselt progresseeruvat haigust stabiliseerida teiste sobivate meetmete abil. patsientidel, kellel on esinenud taastekkinud/tulekindlad haiguste ja patsientidel, kes ei saavutanud täieliku vastuse pärast esimese rea ravi, qarziba tuleks koos interleukiin 2 (il 2).

Euroopa Liit - eesti - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastoom - antineoplastilised ained - unituxin on näidustatud suure riskiga neuroblastoma patsienti vanuses 12 kuud kuni 17-aastased, kes on varem saanud induktsioon keemiaravi ja saavutatud vähemalt osaline ravivastus, kes saavad müeloablatiivset ravi ja vereloome tüvirakkude siirdamist (asct). seda manustatakse kombinatsioonis granulotsüütide ja makrofaagide kolooniat stimuleeriva faktoriga (gm-csf), interleukiin-2 (il-2) ja isotretinoiiniga.

Euroopa Liit - eesti - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - lümfoom, b-raku - antineoplastilised ained - polivy koos bendamustine ja rituksimabi on näidustatud ravi täiskasvanud patsientidel, kellel on taastekkinud/tulekindlad hajus suur b-rakulise lümfoomi (dlbcl), kes ei ole kandidaadid vereloome tüvirakkude siirdamist. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Euroopa Liit - eesti - EMA (European Medicines Agency)

recordati netherlands b.v. - siltuksimab - hiiglane lümfisõlme hüperplaasia - immunosupressandid - sylvant on näidustatud multicentric castleman haigus (mcd, kes on inimese immuunpuudulikkuse viiruse (hiv) negatiivne ja inimese herpesviirus-8 (hhv-8) negatiivne.

Euroopa Liit - eesti - EMA (European Medicines Agency)

sandoz gmbh - rituksimab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - antineoplastilised ained - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. ainult piiratud andmed on saadaval efektiivsust ja ohutust patsientidel, eelnevalt ravitud monoklonaalsete antikehadega (sealhulgas rituksimabi või patsientidel, tulekindlad, et eelmise rituksimabi pluss kemoteraapiat. vt lõik 5. 1 lisateavet. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituksimabi on näidanud, et vähendada määra progressioon ühise kahju, mida mõõdetakse x-ray ja parandab füüsilist funktsiooni, kui antud koos metotreksaadi. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Euroopa Liit - eesti - EMA (European Medicines Agency)

sandoz gmbh - rituksimab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis; microscopic polyangiitis; pemphigus - antineoplastilised ained - rixathon is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rixathon is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. rixathon monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. rixathon is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. rixathon in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). krooniline lümfoidne leukeemia (cll)rixathon kombinatsioonis keemiaraviga on näidustatud patsientide raviks eelnevalt ravimata ja taastekkinud/tulekindlad krooniline lümfotsütaarne leukeemia. ainult piiratud andmed on saadaval efektiivsust ja ohutust patsientidel, eelnevalt ravitud monoklonaalsete antikehadega (sealhulgas rituksimabi või patsientidel, tulekindlad, et eelmise rituksimabi pluss kemoteraapiat. vt lõik 5. 1 lisateavet. reumatoidartriidi arthritisrixathon koos metotreksaadi on näidustatud ravi täiskasvanud patsientidel, kellel on raske aktiivne reumatoidartriit, kes on ebaadekvaatne reaktsioon või talu teisi haigust moduleeriva anti-reumaatilised ravimeid (dmard), sh ühte või enamat tuumori nekroosi faktori (tnf) inhibiitorite ravi. rituksimabi on näidanud, et vähendada määra progressioon ühise kahju, mida mõõdetakse x-ray ja parandab füüsilist funktsiooni, kui antud koos metotreksaadi. granulomatosis with polyangiitis and microscopic polyangiitisrixathon, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). rixathon, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisrixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Euroopa Liit - eesti - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituksimab - lymphoma, non-hodgkin; arthritis, rheumatoid; wegener granulomatosis; leukemia, lymphocytic, chronic, b-cell; microscopic polyangiitis - antineoplastilised ained - truxima on näidatud täiskasvanute jaoks järgmisi andmeid:mitte-hodgkini lümfoom (nhl)truxima on näidustatud raviks eelnevalt ravimata patsientidel iii etapp iv follikulaarne lümfoom kombinatsioonis keemiaraviga. truxima säilitusravi, on näidustatud ravi follikulaarne lümfoom patsientide reageerimine induktsiooni teraapia. truxima monotherapy on näidustatud patsientidele, kellel iii etapp iv follikulaarne lümfoom, kes on kemo vastupidavad või on oma teine või järgmine hakkavad pärast keemiaravi. truxima on näidustatud patsientide raviks cd20 positiivne hajus suur b-rakkude mitte hodgkini lümfoom koos karbonaad (tsüklofosfamiid, doxorubicin, vincristine, prednisoloon) keemiaravi. krooniline lümfoidne leukeemia (cll)truxima kombinatsioonis keemiaraviga on näidustatud patsientide raviks eelnevalt ravimata ja taastekkinud/tulekindlad cll. on kättesaadavad ainult piiratud andmed selliste ravimite efektiivsuse ja ohutuse kohta, mida varem raviti monoklonaalsete antikehadega, sh truxima'ga või eelneva truxima ja kemoteraapiat põdevate patsientidega. reumatoidartriidi arthritistruxima koos metotreksaadi on näidustatud ravi täiskasvanud patsientidel, kellel on raske aktiivne reumatoidartriit, kes on ebaadekvaatne reaktsioon või talu teisi haigust moduleeriva anti reumaatilised ravimeid (dmard), sh ühte või enamat tuumori nekroosi faktori (tnf) inhibiitorite ravi. truxima on näidanud, et vähendada määra progressioon ühise kahju, mida mõõdetakse x-ray ja parandab füüsilist funktsiooni, kui antud koos metotreksaadi. granulomatosis koos polyangiitis ja mikroskoopilised polyangiitistruxima, koos glucocorticoids, on näidustatud ravi täiskasvanud patsientidel, kellel on raske, aktiivse granulomatosis koos polyangiitis (wegener ' s) (gpa) ja mikroskoopilised polyangiitis (mpa). pemphigus vulgaristruxima on näidustatud ravi patsientidel, kellel on mõõdukas kuni raske pemphigus vulgaris (pv).

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck europe b.v.  - tsetuksimab - head and neck neoplasms; colorectal neoplasms - antineoplastilised ained - erbitux on näidustatud patsientide raviks epidermaalse kasvufaktori retseptori (egfr)-väljendades, ras metsikut tüüpi metastaatilise kolorektaalse vähi:koos irinotecan põhineva keemiaravi;esimene on-line kombinatsioonis folfox;ühe esindaja patsientidel, kes on jätnud oxaliplatin - ja irinotecan põhinev teraapia ja kes ei talu, et irinotecan. Üksikasju vaata punkt 5. erbitux on näidustatud ravi patsientidel, kellel on soomusrakuline rakkude vähk pea ja kaela:koos kiiritusravi puhul lokaalselt kaugelearenenud haigusega;koos platinum põhineva keemiaravi jaoks korduva ja/või metastaatilise haiguse.