Avrupa Birliği - Çekçe - EMA (European Medicines Agency)

sandoz gmbh - rivastigminu - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - symptomatická léčba mírné až středně těžké alzheimerovy demence. symptomatická léčba mírné až středně závažné demence u pacientů s idiopatickou parkinsonovou chorobou.

Avrupa Birliği - Çekçe - EMA (European Medicines Agency)

novartis europharm limited - rivastigminu - alzheimer disease; parkinson disease; dementia - psychoanaleptics, - symptomatická léčba mírné až středně těžké alzheimerovy demence. symptomatická léčba mírné až středně závažné demence u pacientů s idiopatickou parkinsonovou chorobou.

Avrupa Birliği - Çekçe - EMA (European Medicines Agency)

actavis group ptc ehf - rivastigmin hydrogen tartarát - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - symptomatická léčba mírné až středně těžké alzheimerovy demence. symptomatická léčba mírné až středně závažné demence u pacientů s idiopatickou parkinsonovou chorobou.

Avrupa Birliği - Çekçe - EMA (European Medicines Agency)

astellas pharma europe b.v. - gilteritinib fumarát - leukemie, myeloidní, akutní - antineoplastická činidla - xospata je indikován jako monoterapie k léčbě dospělých pacientů s relabující nebo refrakterní akutní myeloidní leukémie (aml) s flt3 mutace.

Avrupa Birliği - Çekçe - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - odmítnutí štěpu - imunosupresiva - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Avrupa Birliği - Çekçe - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesylátu - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastická činidla - 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. pacienti, kteří mají nízkou nebo velmi nízkým rizikem recidivy by neměli dostávat adjuvantní léčba. 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. kromě nově diagnostikované chronické fáze cml nejsou k dispozici kontrolované studie, které by prokázaly klinický přínos nebo prodloužené přežití u těchto uvedených onemocnění.

Avrupa Birliği - Çekçe - EMA (European Medicines Agency)

amgen europe bv - sotorasib - karcinom, plicní jiná než malobuněčná - antineoplastická činidla - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.

Çek Cumhuriyeti - Çekçe - SUKL (Státní ústav pro kontrolu léčiv)

almirall hermal gmbh, reinbek array - 1680 fluoruracil; 1274 kyselina salicylovÁ - kožní roztok - 5mg/g+100mg/g - fluoruracil, kombinace

Çek Cumhuriyeti - Çekçe - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 12904 metoprolol-sukcinÁt - tableta s prodlouženým uvolňováním - 100mg - metoprolol

Çek Cumhuriyeti - Çekçe - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 12904 metoprolol-sukcinÁt - tableta s prodlouženým uvolňováním - 200mg - metoprolol