Evropská unie - čeština - 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.

Evropská unie - čeština - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastická činidla - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

Evropská unie - čeština - EMA (European Medicines Agency)

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.

Evropská unie - čeština - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - difelikefalin - pruritus - všechny ostatní terapeutické přípravky - kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis (see section 5.

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

fresenius kabi s.r.o., praha array - 3299 amikacin-disulfÁt - infuzní roztok - 5mg/ml - amikacin

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

zaklady farmaceutyczne polpharma sa, starogard gdański array - 1395 sulfamethoxazol; 1490 trimethoprim - koncentrát pro infuzní roztok - 80mg/ml+16mg/ml - sulfamethoxazol a trimethoprim

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

fresenius kabi s.r.o., praha array - 2126 klindamycin-fosfÁt - injekční roztok/koncenrát pro infuzní roztok - 150mg/ml - klindamycin

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

noridem enterprises limited, nikosia array - 2126 klindamycin-fosfÁt - injekční/infuzní roztok - 150mg/ml - klindamycin

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

noridem enterprises limited, nikosia array - 404 sodnÁ sŮl kolistimethÁtu - prášek pro injekční/infuzní roztok - 1miu - kolistin

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

noridem enterprises limited, nikosia array - 404 sodnÁ sŮl kolistimethÁtu - prášek pro injekční/infuzní roztok - 2miu - kolistin