Európska únia - slovenčina - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastické činidlá - 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 ako monotherapy je indikovaný na liečbu dospelých pacientov s lokálne pokročilým alebo metastatickým nsclc po predchádzajúcej chemoterapie. 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 ako monotherapy je indikovaný na liečbu dospelých pacientov s lokálne pokročilým alebo metastatickým nsclc po predchádzajúcej chemoterapie. 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.

Európska únia - slovenčina - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - astma - drogy obštrukčnej choroby dýchacích ciest, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Európska únia - slovenčina - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektívne imunosupresíva - ulcerózna colitisentyvio je indikovaný na liečbu dospelých pacientov s mierne až ťažkou aktívnou ulcerózna kolitída, ktorí mali nedostatočnú odpoveď s, stratil odpoveď, alebo boli netolerantné buď konvenčnej terapie alebo nádor nekrotizujúci faktor alfa (tnfa) antagonista. crohnova diseaseentyvio je indikovaný na liečbu dospelých pacientov s mierne až ťažkou aktívnou crohnova choroba, ktorí mali nedostatočnú odpoveď s, stratil odpoveď, alebo boli netolerantné buď konvenčnej terapie alebo nádor nekrotizujúci faktor alfa (tnfa) antagonista. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Európska únia - slovenčina - EMA (European Medicines Agency)

eli lilly nederland b.v. - mirikizumab - kolitída, ulceratívna - imunosupresíva - omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.

Európska únia - slovenčina - EMA (European Medicines Agency)

janssen-cilag international nv - ustekinumab - psoriasis; arthritis, psoriatic; crohn disease; colitis, ulcerative - imunosupresíva - crohnova diseasestelara je indikovaný na liečbu dospelých pacientov s mierne až ťažkou aktívnou crohnova choroba, ktorí mali nedostatočnú odpoveď s, stratil odpoveď, alebo boli netolerantné buď konvenčnej terapie alebo tnfa antagonista, alebo majú zdravotné kontraindikácie pre takéto terapie. ulcerózna colitisstelara je indikovaný na liečbu dospelých pacientov s mierne až ťažkou aktívnou ulcerózna kolitída, ktorí mali nedostatočnú odpoveď s, stratil odpoveď, alebo boli netolerantné buď konvenčnej terapie alebo biologických alebo majú zdravotné kontraindikácie pre takéto terapie. doska psoriasisstelara je indikovaný na liečbu stredne silnej až silnej ložiskovej psoriázy u dospelých pacientov, ktorí nereagovali na, alebo ktorí majú kontraindikácie alebo netolerujú iné systémové terapie, vrátane ciclosporin, metotrexát a psoralens ultrafialové. detská doska psoriasisstelara je indikovaný na liečbu stredne silnej až silnej ložiskovej psoriázy u detí a dospievajúcich pacientov vo veku 6 rokov a starších, ktorí sú nedostatočne kontrolované, alebo netolerujú iné systémové terapie alebo phototherapies. psoriatická arthritisstelara, samostatne alebo v kombinácii s metotrexátom, je indikovaná na liečbu aktívnej psoriatická artritída u dospelých pacientov, ak odpoveď na predchádzajúcu non-biologické ochorenia-úprava antirheumatic drog (dmard) terapia bola neprimeraná.