Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - aġenti antineoplastiċi - blitzima huwa indikat fl-adulti għall-indikazzjonijiet li ġejjin:mhux ta 'hodgkin (nhl)blitzima huwa indikat għall-kura ta' pazjenti mhux trattati qabel ma l-istadju iii-iv limfoma follikulari flimkien mal-kimoterapija. blitzima terapija ta 'manteniment huwa indikat għat-trattament tal-linfoma follikulari-pazjenti li jirrispondu għal terapija ta' induzzjoni. blitzima monoterapija hija indikata għat-trattament ta 'pazjenti b'stadju iii-iv limfoma follikulari li huma kemo-reżistenti jew li qegħdin fit-tieni jew aktar episodju ta' rkadar wara kimoterapija. blitzima huwa indikat għall-kura ta 'pazjenti bil-tixrid pożittiv cd20 taċ-ċelluli b kbar mhux ta' hodgkin il-limfoma f'kombinazzjoni ma ' chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) l-kimoterapija. lewkimja limfoċitika kronika (cll)blitzima flimkien ma 'kimoterapija huwa indikat għat-trattament ta' pazjenti li ma kienux trattati qabel u li reġgħet tfaċċat/refrattarja cll. hemm biss informazzjoni limitata disponibbli fuq l-effikaċja u s-sigurtà għall-pazjenti li qabel kienu kkurati b'antikorpi monoklonali inkluż blitzima jew pazjenti refrattarji għal preċedenti blitzima flimkien ma ' kimoterapija.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - aġenti antineoplastiċi - rituzena huwa indikat fl-adulti għall-indikazzjonijiet li ġejjin:mhux ta 'hodgkin (nhl)rituzena huwa indikat għall-kura ta' pazjenti mhux trattati qabel ma l-istadju iii-iv limfoma follikulari flimkien mal-kimoterapija. rituzena monoterapija hija indikata għat-trattament ta 'pazjenti b'stadju iii-iv limfoma follikulari li huma kemo reżistenti jew li qegħdin fit-tieni jew aktar episodju ta' rkadar wara kimoterapija. rituzena huwa indikat għall-kura ta 'pazjenti bil-tixrid pożittiv cd20 taċ-ċelluli b kbar mhux ta' hodgkin il-limfoma f'kombinazzjoni ma ' chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) l-kimoterapija. lewkimja limfoċitika kronika (cll)rituzena flimkien ma 'kimoterapija huwa indikat għat-trattament ta' pazjenti li ma kienux trattati qabel u li reġgħet tfaċċat/refrattarja cll. hemm biss informazzjoni limitata disponibbli fuq l-effikaċja u s-sigurtà għall-pazjenti li qabel kienu kkurati b'antikorpi monoklonali inkluż rituzenaor pazjenti refrattarji għal preċedenti rituzena flimkien ma ' kimoterapija. granulomatosi b'polianġite u mikroskopika polyangiitisrituzena, flimkien ma 'glukokortikosterojdi, huwa indikat għall-induzzjoni ta' remissjoni f'pazjenti adulti b'mard sever, attiv granulomatosi b'polianġite (wegener) (fap) u polianġite mikroskopika (mpa).

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis; microscopic polyangiitis; pemphigus - aġenti antineoplastiċi - 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). lewkimja limfoċitika kronika (cll)rixathon flimkien ma 'kimoterapija huwa indikat għat-trattament ta' pazjenti li ma kienux trattati qabel u li reġgħet tfaċċat/refrattarja ta ' lewkimja limfoċitika kronika. hemm biss informazzjoni limitata disponibbli fuq l-effikaċja u s-sigurtà għall-pazjenti li qabel kienu kkurati b'antikorpi monoklonali inkluż rituximab jew pazjenti refrattarji għal preċedenti rituximab flimkien ma ' kimoterapija. ara t-taqsima 5. 1 għal aktar informazzjoni. rewmatika arthritisrixathon flimkien ma 'methotrexate huwa indikat għall-kura ta' pazjenti adulti b' ' l-artrite rewmatika attiva severa li kellhom rispons inadegwat jew intolleranza għal oħra li timmodifika l-marda anti-rewmatiċi-mediċini (dmard) fosthom wieħed jew aktar tal-fattur tan-nekrożi tat-tumur (tnf) inibitur terapiji. rituximab wera li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. 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).

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

intervet international b.v. - iċ-ċelloli assoċjati jgħixu rikombinanti turkija herpesvirus (razza hvp360), li jesprimu l-proteina tal-fużjoni ta nd-virus u l-vp2-proteina tal-virus ibd - tat-tjur tal-erpete (marek tal-marda) + avjarja l-marda burżali infettiva tal-virus (marda gumboro) + newcastle-virus tal-marda/paramyxovirus - chicken; embryonated chicken eggs - for active immunisation of one-day-old chicks or 18-19-day-old embryonated chicken eggs:to reduce mortality and clinical signs caused by newcastle disease (nd) virus,to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (ibd) virus,to reduce mortality, clinical signs and lesions caused by marek’s disease (md) virus.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

recordati netherlands b.v. - tienzanib - karċinoma, Ċellula renali - aġenti antineoplastiċi - fotivda huwa indikat għall-ewwel trattament linja ta ' l-adulti pazjenti b ' karċinoma taċ-ċelluli renali avvanzati (rcc) u għall-pazjenti adulti li huma vegfr u mtor il-mogħdija inhibitor-naïve wara progressjoni tal-marda wara t-trattament minn qabel waħda ma cytokine terapija għall rcc avvanzati. it-trattament ta ' karċinoma taċ-ċellola renali.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

amgen technology (ireland) uc - bevacizumab - carcinoma, renal cell; peritoneal neoplasms; ovarian neoplasms; breast neoplasms; carcinoma, non-small-cell lung; fallopian tube neoplasms - aġenti antineoplastiċi - mvasi flimkien ma ' bbażati fuq il-fluoropyrimidine chemotherapy huwa indikat għall-kura tal-pazjenti adulti b ' karċinoma metastatic ta-colon jew rectum. mvasi f'kombinazzjoni ma 'paclitaxel, huwa indikat għall-kura preferita ta' pazjenti adulti b'kanċer metastatiku tas-sider. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. mvasi, barra minn hekk 'kimoterapija bbażata fuq platinum, huwa ndikat għall-kura preferita ta' pazjenti adulti li ma jistax jitneħħa, avvanzat, li mmetastatizza jew rikorrenti taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija ta ' ċelluli skwamużi. mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. mvasi, f'kombinazzjoni ma 'carboplatin u paclitaxel huwa ndikat għall-quddiem il-linja ta 'trattament ta' pazjenti adulti b'avvanzati (il-federazzjoni internazzjonali tal-mard tal-ġilda u l-ostetriċja (medjevali) istadji iiib, iii u iv) ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan, jew primarja peritoneali-kanċer. mvasi, f'kombinazzjoni ma 'carboplatin u gemcitabine jew f'kombinazzjoni ma' carboplatin u paclitaxel, huwa indikat għall-kura ta 'pazjenti adulti bil-ewwel rikorrenza tal-sensittiva għall-platinum ta' l-epitilju ta 'l-ovarji, l-tubu fallopjan jew primarja peritoneali-kanċer li ma rċevew terapija minn qabel ma' bevacizumab, jew l-oħra ' impedituri vegf jew vegf-riċetturi fil-mira l-aġenti. mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. mvasi, flimkien ma 'paclitaxel u cisplatin jew, alternattivament, paclitaxel u topotecan f'pazjenti li ma jistgħux jirċievu l-platinum-terapija, huwa indikat għall-kura ta' pazjenti adulti b'persistenti, rikorrenti, jew karċinoma metastatika taċ-ċerviċi.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - aġenti antineoplastiċi - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq bħala monoterapija hija indikata għat-trattament ta ' pazjenti adulti b'lokalment avvanzat jew metastatiku nsclc wara l-kimoterapija qabel. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq bħala monoterapija hija indikata għat-trattament ta ' pazjenti adulti b'lokalment avvanzat jew metastatiku nsclc wara l-kimoterapija qabel. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase alkpositive advanced nsclc previously treated with crizotinib.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

mylan pharmaceuticals limited - gefitinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - antineoplastic agents, protein kinase inhibitors - gefitinib mylan huwa indikat bħala monoterapija għall-kura ta 'pazjenti adulti b'lokalment avvanzat jew dak metastatiku li mhux ta' ċelluli żgħar kanċer tal-pulmun (nsclc) b'mutazzjonijiet li jattivaw ta ' egfr‑tk.