Den europeiske union - rumensk - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis; microscopic polyangiitis; pemphigus - agenți antineoplazici - 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). leucemia limfocitară cronică (llc)rixathon în asociere cu chimioterapie este indicat pentru tratamentul pacienților cu netratați anterior și refractar/recidivat, leucemie limfocitară cronică. sunt disponibile doar date limitate privind eficacitatea și siguranța pentru pacienții tratați anterior cu anticorpi monoclonali inclusiv rituximab sau pacienții refractari la anterior cu rituximab plus chimioterapie. a se vedea secțiunea 5. 1 pentru informații suplimentare. poliartrita arthritisrixathon în asociere cu metotrexat este indicat pentru tratamentul pacienților adulți cu poliartrită reumatoidă activă, severă, care au avut un răspuns inadecvat sau intoleranță la alte boli medicamente antireumatice modificatoare (mamb), inclusiv una sau mai multe factorul de necroză tumorală (tnf) inhibitor de terapii. rituximab a fost demonstrat de a reduce rata progresiei distrucției articulare prin x-ray și de a îmbunătăți funcția fizică, atunci când este administrat în asociere cu metotrexat. 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).

Den europeiske union - rumensk - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - agenți antineoplazici - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Den europeiske union - rumensk - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - neoplasme ovariene - agenți antineoplazici - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. rubraca este indicat în monoterapie pentru tratamentul de întreținere al pacienților adulți cu platină sensibile recidivat de înaltă calitate epitelial ovarian, al trompelor uterine sau cancer peritoneal primar care sunt în răspuns (completă sau parțială) la chimioterapia pe bază de platină.

Den europeiske union - rumensk - EMA (European Medicines Agency)

pfizer europe ma eeig - talazoparib - sânii neoplasme - agenți antineoplazici - talzenna este indicat în monoterapie pentru tratamentul pacienților adulți cu liniei germinale brca1/2 mutatii, care au her2-negativ, avansat local sau metastatic, cancer de sân. patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. pacientele cu receptori hormonali (hr)-pozitiv cancer de san ar trebui să au fost tratate cu o prealabilă endocrine-terapie pe bază de, sau să fie considerate nepotrivite pentru endocrin-terapie pe bază de.

Den europeiske union - rumensk - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - agenți antineoplazici - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. chimioterapia anterioară trebuie să fi inclus cel puțin o antraciclină și un taxan excepția cazului în care pacienții sunt improprii pentru aceste tratamente. receptor hormonal pozitiv pacienții trebuie să aibă, de asemenea, nu a reușit tratament hormonal, cu excepția cazului în care pacienții sunt improprii pentru aceste tratamente.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. în asociere cu docetaxel pentru tratamentul pacienților care nu au primit anterior chimioterapie pentru boala lor metastatică. în combinație cu un inhibitor de aromatază pentru tratamentul de paciente în postmenopauză cu hormon-receptor pozitiv mbc, nu au fost tratați anterior cu trastuzumab. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). după intervenție chirurgicală, chimioterapie (neoadjuvantă sau adjuvantă) și radioterapie (dacă este cazul). următoarele chimioterapie adjuvantă cu doxorubicină și ciclofosfamidă, în asociere cu paclitaxel sau docetaxel. în combinație cu chimioterapie adjuvantă format din docetaxel și carboplatină. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. precise și validate metode de testare ar trebui să fie utilizate.

Den europeiske union - rumensk - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - sânii neoplasme - agenți antineoplazici - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Den europeiske union - rumensk - EMA (European Medicines Agency)

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - agenți antineoplazici - tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with her2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑her2 treatment regimens.

Den europeiske union - rumensk - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - agenți antineoplazici - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Den europeiske union - rumensk - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

Den europeiske union - rumensk - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilat - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - agenți antineoplazici - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacienții care au un risc scăzut sau foarte scăzut de recidivă nu trebuie să primească tratament adjuvant. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. cu excepția nou diagnosticate în faza cronică a lgc, nu există studii controlate care să demonstreze un beneficiu clinic sau a crescut de supraviețuire pentru aceste boli.