European Union - Lithuanian - 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.

European Union - Lithuanian - EMA (European Medicines Agency)

eli lilly nederland b.v. - olaratumab - sarkoma - antinavikiniai vaistai - lartruvo skiriamas derinyje su doksorubicino gydant suaugusius pacientus, sergančius progresavusia minkštųjų audinių sarkoma, kurie nėra etiologinio gydymo su chirurgija ar radioterapija gali būti taikoma ir kurie nebuvo anksčiau gydyti doksorubicino (žr. 5 skirsnis.

European Union - Lithuanian - EMA (European Medicines Agency)

masitinibas - virškinimo trakto stromos navikai - baltymų kinazės inhibitoriai - gydymo unresectable ir/arba metastazavusio piktybinių virškinimo trakto stromos navikas (gist).

European Union - Lithuanian - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinibas - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antinavikiniai vaistai - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

European Union - Lithuanian - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antinavikiniai vaistai - 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. pacientams, kurie turi mažai arba labai mažai rizikos, pasikartojimo neturėtų gauti oksaliplatina. 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. išskyrus naujai diagnozuota lėtinė fazė lml, nėra kontroliuojamų tyrimų rodo, klinikinės naudos ar padidėjo išgyvenamumas šių ligų.

European Union - Lithuanian - EMA (European Medicines Agency)

astrazeneca ab - tezepelumab - astma - vaistai nuo obstrukcinių kvėpavimo takų ligų, - tezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

European Union - Lithuanian - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hepatitas b, rekombinantinis paviršinis antigenas - hepatitis b; immunization - vakcinos - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. konkrečios rizikos kategorijoms bus paskiepyti, turi būti nustatoma remiantis oficialiomis rekomendacijomis. galima tikėtis, kad hepatito d, taip pat bus užkirstas kelias imunizacijos su hbvaxpro kaip hepatitas d (sukelia delta agentas) neturi atsirasti nesant hepatito b infekcijos. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. konkrečios rizikos kategorijoms bus paskiepyti, turi būti nustatoma remiantis oficialiomis rekomendacijomis. galima tikėtis, kad hepatito d, taip pat bus užkirstas kelias imunizacijos su hbvaxpro kaip hepatitas d (sukelia delta agentas) neturi atsirasti nesant hepatito b infekcijos. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. galima tikėtis, kad hepatito d, taip pat bus užkirstas kelias imunizacijos su hbvaxpro kaip hepatitas d (sukelia delta agentas) neturi atsirasti nesant hepatito b infekcijos.

European Union - Lithuanian - 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. .

European Union - Lithuanian - EMA (European Medicines Agency)

teva b.v. - imatinibas - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva fluorouracilu ir folino ofadult ir vaikų pacientams su naujai diagnozuota filadelfijos chromosoma (pot‑abl) teigiamas (ph+) lėtinės mieloidinės leukemijos (lml), kuriems kaulų čiulpų transplantacija nėra laikomi pirmos eilės gydymo. suaugusiųjų ir vaikų pacientams, kurių ph+ lml lėtinės fazės, kai sugenda interferonu‑alfa terapija, arba pagreitinto etapas arba sprogimo krizės. suaugusiųjų ir vaikų pacientams su naujai diagnozuota filadelfijos chromosoma teigiamas ūmios limfoblastinės leukemijos (ph+ visi) integruota su chemoterapija. suaugusių pacientų su atsinaujino arba ugniai atsparios ph+ visi kaip monotherapy. suaugusių pacientų su mielodisplazinio/myeloproliferative ligų (vni/mpl), susijusių su trombocitų gautas augimo faktoriaus receptorius (pdgfr) genų iš naujo tvarka. suaugę pacientai, sergantys progresavusia hypereosinophilic sindromas (hes) ir (arba) lėtinio eosinophilic leukemija (cel) su fip1l1-pdgfra persigrupavimas. poveikis imatinib rezultatus kaulų čiulpų transplantacijos nenustatyta. imatinib teva 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. pacientams, kurie turi mažai arba labai mažai rizikos, pasikartojimo neturėtų gauti oksaliplatina. 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. išskyrus naujai diagnozuota lėtinė fazė lml, nėra kontroliuojamų tyrimų rodo, klinikinės naudos ar padidėjo išgyvenamumas šių ligų.

European Union - Lithuanian - EMA (European Medicines Agency)

novartis europharm ltd - ofatumumab - leukemija, limfocitinė, lėtinė, b-ląstelė - monokloniniai antikūnai - anksčiau negydytų lėtine limfocitine leukemija (lll): arzerra kartu su chlorambucil ar bendamustine skiriamas pacientams, sergantiems lll kurie nėra gavę iki terapijos ir kurie negali gauti fludarabine-pagrįstas terapija. atsinaujino lll: arzerra yra nurodytas kartu su fludarabine ir ciklofosfamidu gydyti suaugusiems pacientams, sergantiems atsinaujino lll. ugniai atsparūs lll: arzerra nurodomas gydymo lll pacientams, kurie yra neatsparūs į fludarabine ir alemtuzumab.