Union européenne - slovaque - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir - hepatitída c, chronická - antivirotiká na systémové použitie - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients 3 years of age and older (see sections 4. 2, 4. 4 a 5.

Union européenne - slovaque - EMA (European Medicines Agency)

hexal ag - epoetín alfa - anemia; kidney failure, chronic; cancer - 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. , liečbu anémie a zníženie transfúziu požiadavky u dospelých pacientov, ktorí dostávajú chemoterapiu na solídne nádory, malígny lymfóm alebo myelómom je mladších, a na riziko transfúziu, ako sa posudzuje celkový stav pacienta (e. kardiovaskulárny stav, existujúce anémie na začiatku chemoterapia).

Union européenne - slovaque - EMA (European Medicines Agency)

ratiopharm gmbh - epoetínu theta - kidney failure, chronic; anemia; cancer - iné prípravky protianemický - liečba symptomatickej anémie spojenej s chronickým zlyhaním obličiek u dospelých pacientov. liečbu symptomatických anémia u dospelých pacientov s rakovinou s non-myeloidná malignancies dostávajú chemoterapiu.

Union européenne - slovaque - EMA (European Medicines Agency)

abbvie ltd - dasabuvir sodný - hepatitída c, chronická - antivirotiká na systémové použitie - exviera je indikovaná v kombinácii s inými liekmi na liečbu chronickej hepatitídy c (chc) u dospelých. pre vírusom hepatitídy c (hcv) genotyp konkrétnu činnosť.

Union européenne - slovaque - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozín propándiol monohydrát - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lieky používané pri cukrovke - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. okrem iných liekov na liečbu diabetes mellitus 2. typu. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 a 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Union européenne - slovaque - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastické činidlá - glivec is indicated for the treatment of , adult 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-pdgfra rearrangement. Účinok glivec na výsledok kostnej drene transplantácia nebola stanovená. glivec is indicated for: , the 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, ktorí majú nízky alebo veľmi nízke riziko opakovania by nemalo prijímať adjuvantnej liečby, liečba dospelých pacientov s unresectable dermatofibrosarcoma protuberans (dfsp) a u dospelých pacientov s recidivujúcim a / alebo metastatickým dfsp, ktorí nie sú akceptovateľné pre operácie. , u dospelých a pediatrických pacientov, účinnosť glivec je založené na celkovej hematologické a cytogenetic odpoveď ceny a postup-zadarmo prežitie v cml, na hematologické a cytogenetic miera odozvy v ph+ all, mds / mpd, na hematologické miera odozvy v hes / cel a na cieľ miera odozvy u dospelých pacientov s unresectable a / alebo metastatickým podstata a dfsp a na opakovanie-free prežitie v adjuvantnej tÉmou. skúsenosti s glivec u pacientov s mds / mpd spojené s pdgfr gén re-opatrenia je veľmi obmedzené (pozri časť 5. okrem novo diagnostikovaných chronickej fáze cml, nie sú tam žiadne kontrolovaných štúdií dokazuje, klinický prospech alebo zvýšené prežitie týchto ochorení.

Union européenne - slovaque - EMA (European Medicines Agency)

gilead sciences ireland uc - ledipasvir, sofosbuvir - hepatitída c, chronická - antivirotiká na systémové použitie - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 a 5. pre vírusom hepatitídy c (hcv) genotyp-konkrétne aktivity pozri časť 4. 4 a 5.

Union européenne - slovaque - EMA (European Medicines Agency)

gilead sciences ireland uc - adefovir-dipivoxil - hepatitída b, chronická - nukleozidové a nukleotidové inhibítory reverznej transkriptázy - hepsera je indikovaný na liečbu chronickej hepatitídy b u dospelých pacientov s:kompenzované ochorenie pečene s dôkazmi o aktívne vírusovej replikácie, vytrvalo zvýšené sérové-alanín-aminotransferase (alt) úrovne a histologický dôkaz aktívny zápal pečene a fibróza. začatie hepsera liečby by sa malo zvažovať len vtedy, keď je používanie alternatívneho protivírusové agent s vyššou genetickou bariérou rezistencie nie je k dispozícii alebo je to vhodné (pozri časť 5. 1);decompensated ochorenia pečene v kombinácii s druhým agent bez krížovej rezistencie na hepsera.

Union européenne - slovaque - EMA (European Medicines Agency)

novartis europharm limited - indakaterol maleát - pľúcna choroba, chronická obštrukcia - drogy obštrukčnej choroby dýchacích ciest, - hirobriz breezhaler je indikovaný na udržiavanie bronchodilatačnej liečby obštrukcie prúdenia vzduchu u dospelých pacientov s chronickou obštrukčnou chorobou pľúc.

Union européenne - slovaque - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult 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. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. okrem novo diagnostikovaných chronickej fáze cml, nie sú tam žiadne kontrolovaných štúdií dokazuje, klinický prospech alebo zvýšené prežitie týchto ochorení. .