Sutent Европска Унија - Чешки - EMA (European Medicines Agency)

sutent

pfizer limited - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastická činidla - gastrointestinal stromal tumour (gist)sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. experience with sutent as first-line treatment is limited (see section 5.

Sunitinib Accord Европска Унија - Чешки - EMA (European Medicines Agency)

sunitinib accord

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastická činidla - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Qinlock Европска Унија - Чешки - EMA (European Medicines Agency)

qinlock

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinální stromální nádory - antineoplastická činidla - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Stivarga Европска Унија - Чешки - EMA (European Medicines Agency)

stivarga

bayer pharma ag - regorafenib - kolorektální novotvary - antineoplastic agents, protein kinase inhibitors - stivarga je indikován jako monoterapie k léčbě dospělých pacientů s:metastazujícím kolorektálním karcinomem (crc), kteří byli dříve léčeni, nebo nejsou považovány za kandidáty pro, k dispozici terapie - patří mezi ně fluoropyrimidinových na bázi chemoterapie, anti-vegf léčbu a anti-egfr terapie;inoperabilním nebo metastazujícím gastrointestinálním stromálním tumorem (gist), kteří vyvíjí nebo netolerují předchozí léčby u imatinib a sunitinib;hepatocelulární karcinom (hcc), kteří byli dříve léčeni sorafenibem.

Sprycel Европска Унија - Чешки - EMA (European Medicines Agency)

sprycel

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastická činidla - sprycel je indikován k léčbě dětských pacientů s:nově diagnostikovanou philadelphia chromozom pozitivní chronickou myeloidní leukémií v chronické fázi (ph+ cp cml) nebo ph+ cp cml rezistentních nebo intolerantních k předchozí léčbě včetně imatinibu -. nově diagnostikovanou ph+ akutní lymfoblastickou leukemií (all) v kombinaci s chemoterapií. sprycel je indikován k léčbě dospělých pacientů s:nově diagnostikovanou philadelphia chromozom pozitivní (ph+) chronickou myeloidní leukémií (cml) v chronické fázi;chronickou, akcelerovanou nebo blastickou fází cml s rezistencí či intolerancí k předchozí léčbě včetně imatinibu-mesylátu;ph+ akutní lymfoblastickou leukemií (all) a s lymfoidní blastickou cml s rezistencí či intolerancí k předchozí léčbě. sprycel je indikován k léčbě dětských pacientů s:nově diagnostikovanou ph+ cml v chronické fázi (ph+ cml-cp) nebo ph+ cml-cp intolerantní nebo rezistentní na předchozí léčbu zahrnující imatinib.

Dasatinib Accordpharma Европска Унија - Чешки - EMA (European Medicines Agency)

dasatinib accordpharma

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastická činidla - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Lorviqua Европска Унија - Чешки - EMA (European Medicines Agency)

lorviqua

pfizer europe ma eeig - lorlatinib - karcinom, plicní jiná než malobuněčná - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated 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. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.

Alecensa Европска Унија - Чешки - EMA (European Medicines Agency)

alecensa

roche registration gmbh - alectinib hydrochlorid - karcinom, plicní jiná než malobuněčná - antineoplastická činidla - alecensa jako monoterapie je indikován k první linii léčby dospělých pacientů s kinázy anaplastického lymfomu (alk)-pozitivního pokročilého nemalobuněčného karcinomu plic (nsclc). alecensa jako monoterapie je indikován k léčbě dospělých pacientů s alk‑pozitivním pokročilým nsclc, dříve léčených s crizotinib.

Imbruvica Европска Унија - Чешки - EMA (European Medicines Agency)

imbruvica

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Intuniv Европска Унија - Чешки - EMA (European Medicines Agency)

intuniv

takeda pharmaceuticals international ag ireland branch - hydrochloridu guanfacinu - porucha pozornosti s hyperaktivitou - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv musí být použity jako součást komplexní léčby adhd programu, obvykle včetně psychologické, vzdělávací a sociální opatření.