Եվրոպական Միություն - չեխերեն - 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.

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastická činidla - brukinsa as monotherapy 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. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Եվրոպական Միություն - չեխերեն - EMA (European Medicines Agency)

gilead sciences ireland unlimited company - lenacapavir sodium - hiv infekce - antivirotika pro systémové použití - sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant hiv 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4. 2 a 5. sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant hiv 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4. 2 a 5.

Չեխիա - չեխերեն - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 17381 apixaban - potahovaná tableta - 2,5mg - apixaban

Չեխիա - չեխերեն - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 17381 apixaban - potahovaná tableta - 5mg - apixaban

Չեխիա - չեխերեն - SUKL (Státní ústav pro kontrolu léčiv)

gedeon richter plc., budapešť array - 18800 atorvastatin-lysin; 12990 amlodipin-besilÁt - potahovaná tableta - 10mg/10mg - atorvastatin a amlodipin

Չեխիա - չեխերեն - SUKL (Státní ústav pro kontrolu léčiv)

gedeon richter plc., budapešť array - 18800 atorvastatin-lysin; 12990 amlodipin-besilÁt - potahovaná tableta - 10mg/5mg - atorvastatin a amlodipin

Չեխիա - չեխերեն - SUKL (Státní ústav pro kontrolu léčiv)

gedeon richter plc., budapešť array - 18800 atorvastatin-lysin; 12990 amlodipin-besilÁt - potahovaná tableta - 20mg/10mg - atorvastatin a amlodipin

Չեխիա - չեխերեն - SUKL (Státní ústav pro kontrolu léčiv)

gedeon richter plc., budapešť array - 18800 atorvastatin-lysin; 12990 amlodipin-besilÁt - potahovaná tableta - 20mg/5mg - atorvastatin a amlodipin

Չեխիա - չեխերեն - SUKL (Státní ústav pro kontrolu léčiv)

warszawskie zaklady farmaceutyczne polfa s.a., varšava polsko - 16541 amlodipin-maleinÁt; 13182 valsartan; 728 hydrochlorothiazid - potahovaná tableta - 10mg/160mg/12,5mg - valsartan, amlodipin a hydrochlorothiazid