Kesatuan Eropah - Czech - EMA (European Medicines Agency)

novartis europharm ltd - aliskiren, amlodipin - hypertenze - agens působící na systém renin-angiotenzin - přípravek rasilamlo je určen k léčbě esenciální hypertenze u dospělých pacientů, jejichž krevní tlak není dostatečně kontrolován aliskirenem nebo amlodipinem použitým samostatně.

Kesatuan Eropah - Czech - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - macimorelin acetát - diagnostické techniky, endokrinní - macimorelin - tento léčivý přípravek je určen pouze pro diagnostické účely.  ghryvelin is indicated for the diagnosis of growth hormone deficiency (ghd) in adults.

Kesatuan Eropah - Czech - 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.

Republik Czech - Czech - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 13049 perindopril-erbumin; 12990 amlodipin-besilÁt - tableta - 4mg/10mg - perindopril a amlodipin

Republik Czech - Czech - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 13049 perindopril-erbumin; 12990 amlodipin-besilÁt - tableta - 4mg/5mg - perindopril a amlodipin

Republik Czech - Czech - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 13049 perindopril-erbumin; 12990 amlodipin-besilÁt - tableta - 8mg/10mg - perindopril a amlodipin

Republik Czech - Czech - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 13049 perindopril-erbumin; 12990 amlodipin-besilÁt - tableta - 8mg/5mg - perindopril a amlodipin

Republik Czech - Czech - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 12990 amlodipin-besilÁt; 14884 trihydrÁt vÁpenatÉ soli atorvastatinu - potahovaná tableta - 10mg/10mg - atorvastatin a amlodipin

Republik Czech - Czech - SUKL (Státní ústav pro kontrolu léčiv)

baxter czech spol. s r.o., praha array - 1256 retinol-palmitÁt; 402 cholekalciferol; 5465 tokoferol-alfa-rrr; 102 kyselina askorbovÁ; 13244 tetrahydrÁt kokaboxylasy; 1261 dihydrÁt sodnÉ soli riboflavin-fosfÁtu; 1230 pyridoxin-hydrochlorid; 425 kyanokobalamin; 644 kyselina listovÁ; 462 dexpanthenol; 173 biotin; 970 nikotinamid - prášek pro injekční/infuzní roztok - vitaminy

Republik Czech - Czech - SUKL (Státní ústav pro kontrolu léčiv)

egis pharmaceuticals plc, budapešť array - 1610 klomifen-citrÁt - tableta - 50mg - klomifen