Európska únia - slovenčina - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - mačací leukémia vírus rekombinantný canarypox vírus (vcp97) - immunologicals pre felidae, - mačky - aktívna imunizácia mačiek vo veku 8 týždňov alebo starších proti mačacej leukémii na prevenciu pretrvávajúcej virémie a klinických príznakov súvisiacej choroby. nástup imunity bol preukázaný 2 týždne po primárnej vakcinácii. trvanie imunity je jeden rok po poslednej vakcinácii.

Európska únia - slovenčina - EMA (European Medicines Agency)

mylan ireland limited - arzén sírového - leukémia, promyelocytická, akútna - antineoplastické činidlá - arzén sírového mylan je indikovaný na indukčné odpustenia, a konsolidácie v dospelých pacientov s:- novo diagnostikovaných nízke až stredné riziko akútnej promyelocytic leukémia (apl) (bielych krviniek, ≤ 10 x 103/µl) v kombinácii so všetkými trans retinoic acid (atra)- relapsed/žiaruvzdorné akútna promyelocytic leukémia (apl) (predchádzajúca liečba by mala obsahovať retinoid a chemoterapia)charakterizuje prítomnosť t(15;17) translokácia a/alebo prítomnosť promyelocytic leukémia/retinoic acid receptor alfa (pml/rar alfa) gén. návratnosť iné akútne myelogenous leukémia subtypes na arzén sírového nie beenexamined.

Európska únia - slovenčina - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. Účinok imatinib o výsledku transplantáciu kostnej drene nebola stanovená. imatinib actavis is indicated for: , 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 dfsp. skúsenosti s imatinib u pacientov s mds/mpd spojené s pdgfr gén re-opatrenia je veľmi obmedzený. nie sú žiadne kontrolovaných štúdií dokazuje, klinický prospech alebo zvýšené prežitie týchto ochorení.

Európska únia - slovenčina - EMA (European Medicines Agency)

sandoz gmbh - epoetín alfa - anemia; kidney failure, chronic - antianemické prípravky - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis;, treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. kardiovaskulárny stav, existujúce anémie na začiatku chemoterapia).

Európska únia - slovenčina - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic kyseliny - hypercholesterolemia; dyslipidemias - Činidlá modifikujúce lipidy - nilemdo je indikovaný u dospelých s primárnej hypercholesterolémie (heterozygous rodinné a non rodinné), alebo zmiešané dyslipidaemia, ako doplnok k strave:v kombinácii s statin alebo statin s inými lipidov-zníženie terapie u pacientov schopný dosiahnuť ldl c cieľov s maximálna tolerovaná dávka statin (pozri časť 4. 2, 4. 3 a 4. 4), alebo samostatne alebo v kombinácii s inými lipidov-zníženie terapie u pacientov, ktorí sú statin netolerantné, alebo pre koho statin je kontraindikovaný.

Európska únia - slovenčina - EMA (European Medicines Agency)

ultragenyx germany gmbh - evinacumab - hypercholesterolémia - Činidlá modifikujúce lipidy - evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (ldl-c) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (hofh).

Európska únia - slovenčina - EMA (European Medicines Agency)

lipomed gmbh - cladribine - leukémia, chlpatá bunka - antineoplastické činidlá - liek litak je indikovaný na liečbu leukémie vlasatých buniek.

Európska únia - slovenčina - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - leukémia, lymfocytárna, chronická, b-bunka - antineoplastické činidlá - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Európska únia - slovenčina - EMA (European Medicines Agency)

grünenthal gmbh - lesinurad - hyperurikémia - antiguty prípravky - zurampic v kombinácii s inhibítorom xantínoxidázy, je indikovaný u dospelých na prídavná liečba hyperurikémie u pacientov s dnou (s alebo bez tofy) ktorí nedosiahli cieľ sérové hladiny kyseliny močovej s primeranú dávku xantínoxidáza inhibítor sám.

Európska únia - slovenčina - EMA (European Medicines Agency)

roche registration gmbh - methoxy polyetylénglykolu-epoetin beta - anemia; kidney failure, chronic - antianemické prípravky - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.