Evropská unie - čeština - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastická činidla - 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 jako monoterapie je indikován k léčbě dospělých pacientů s lokálně pokročilým nebo metastazujícím nemalobuněčným karcinomem plic po předchozí chemoterapii. 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 jako monoterapie je indikován k léčbě dospělých pacientů s lokálně pokročilým nebo metastazujícím nemalobuněčným karcinomem plic po předchozí chemoterapii. 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.

Evropská unie - čeština - EMA (European Medicines Agency)

elan pharma international ltd. - natalizumab - crohnova choroba - imunostimulancia, - léčba středně závažné až závažné aktivní crohnovy choroby pro redukci známek a příznaků a navození a udržování trvalé odpovědi a remise, u pacientů, kteří nereagovali i přes plnou a adekvátní léčbu kortikosteroidy a imunosupresivní; nebo kteří tuto léčbu netolerují nebo mají zdravotní kontraindikace k takové léčby.

Evropská unie - čeština - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektivní imunosupresiva - ulcerózní colitisentyvio je indikován pro léčbu dospělých pacientů se středně těžkou až těžkou aktivní ulcerózní kolitidou, kteří měli nedostatečnou odpověď, ztratil reakci na, nebo netolerovali buď konvenční terapie, nebo tumor nekrotizující faktor alfa (tnfa) antagonista. crohnova diseaseentyvio je indikován pro léčbu dospělých pacientů se středně těžkou až těžkou aktivní crohnovou chorobou, kteří měli nedostatečnou odpověď, ztratil reakci na, nebo netolerovali buď konvenční terapie, nebo tumor nekrotizující 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.

Evropská unie - čeština - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - astma - léky na obstrukční onemocnění dýchacích cest, - 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.

Evropská unie - čeština - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresiva - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 a 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Evropská unie - čeština - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - roztroušená skleróza - selektivní imunosupresiva - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 a 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Evropská unie - čeština - EMA (European Medicines Agency)

laboratorios lesvi s.l. - dimethyl fumarát - roztroušená skleróza, relaps-remitentní - imunosupresiva - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

egis pharmaceuticals plc, budapešť array - 19410 fingolimod-hydrochlorid - tvrdá tobolka - 0,5mg - fingolimod

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 19410 fingolimod-hydrochlorid - tvrdá tobolka - 0,5mg - fingolimod

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

vipharm s.a., ożarów mazowiecki array - 19410 fingolimod-hydrochlorid - tvrdá tobolka - 0,5mg - fingolimod