Euroopan unioni - liettua - EMA (European Medicines Agency)

biocodex - stiripentolis - miokloninė epilepsija, nepilnamečiai - antiepileptics, - diacomit skirtas naudoti kartu su klobazamu ir valproatu kaip papildoma terapija, ugniai atsparios apibendrintas toninius-kloninius priepuolius pacientams, sergantiems sunkia kūdikių mioklonine epilepsija kūdikystėje (skme, draveto) kurių priepuoliai nėra tinkamai valdomas su klobazamu ir valproatu.

Euroopan unioni - liettua - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozino propanedilo monohidratas - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - narkotikai, vartojami diabetu - type 2 diabetes mellitusedistride 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. be kitų vaistų, skirtų gydyti 2 tipo cukrinis diabetas. 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 ir 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Euroopan unioni - liettua - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir - hepatitas c, lėtinis - antivirusiniai vaistai sisteminiam naudojimui - 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 ir 5.

Euroopan unioni - liettua - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cobicistat, atazanavir - Živ infekcijos - antivirusiniai vaistai sisteminiam naudojimui - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4. 4 ir 5.

Euroopan unioni - liettua - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozino propanedilo monohidratas - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - narkotikai, vartojami diabetu - 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. be kitų vaistų, skirtų gydyti 2 tipo cukrinis diabetas. 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 ir 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.

Euroopan unioni - liettua - EMA (European Medicines Agency)

novartis europharm limited - imatinibas - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antinavikiniai vaistai - 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. poveikis glivec rezultatus kaulų čiulpų transplantacijos nenustatyta. 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. pacientams, kurie turi mažai arba labai mažai rizikos, pasikartojimo neturėtų gauti oksaliplatina;, gydymo suaugusių pacientų su unresectable dermatofibrosarcoma protuberans (dfsp) ir suaugusių pacientų su periodinis ir / arba metastazavusio dfsp kurie negali gauti chirurgija. ,, suaugusiųjų ir vaikų pacientams, veiksmingumą, glivec yra grindžiamas bendro hematologinių ir cytogenetic reagavimo tarifus ir progresavimo-nemokamai išlikimo lml, hematologinių ir cytogenetic atsako dažnis ph+ visi, mds / mpl, hematologinių atsako normos hes / cel ir dėl objektyvių atsakymų lygis suaugusiųjų pacientų su unresectable ir / arba metastazavusio gist ir dfsp ir pasikartojimo-nemokamai išlikimo palaikomosios gist. patirtis su glivec pacientams, sergantiems vni / mpl, susijusių su pdgfr genų vėl priemonės yra labai ribotos (žr. skyrių 5. išskyrus naujai diagnozuota lėtinė fazė lml, nėra kontroliuojamų tyrimų rodo, klinikinės naudos ar padidėjo išgyvenamumas šių ligų.

Euroopan unioni - liettua - EMA (European Medicines Agency)

gilead sciences ireland uc - ledipasvir, sofosbuvir - hepatitas c, lėtinis - antivirusiniai vaistai sisteminiam naudojimui - 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 ir 5. hepatito c viruso (hcv) genotipo-konkrečios veiklos, žr. skirsnius 4. 4 ir 5.

Euroopan unioni - liettua - EMA (European Medicines Agency)

csl behring gmbh - žmogaus normalus imunoglobulinas (scig) - imunologinių trūkumų sindromai - imuninės serumai ir imunoglobulinai, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Euroopan unioni - liettua - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, metforminas hidrochloridas - cukrinis diabetas, 2 tipas - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 ir 5. 1, jei yra duomenų apie skirtingus derinius).

Euroopan unioni - liettua - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinibas - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinibas - 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. išskyrus naujai diagnozuota lėtinė fazė lml, nėra kontroliuojamų tyrimų rodo, klinikinės naudos ar padidėjo išgyvenamumas šių ligų. .