Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antinavikiniai vaistai - imatinib teva b. 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. , pediatrijos pacientų, kurių ph+ lml lėtinės fazės, kai sugenda interferonu-alfa terapija, arba pagreitinto etapas arba sprogimo krizės. , suaugusių pacientų, kurių ph+ lml blast 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 b. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). , oksaliplatina suaugusiems pacientams, kuriems gresia didelė rizika, atkryčio po rezekcija rinkinys (cd117)-teigiama gist. pacientams, kurie turi mažai arba labai mažai rizikos, pasikartojimo neturėtų gauti oksaliplatina. , gydyti suaugusiems pacientams, sergantiems unresectable dermatofibrosarcoma protuberans (dfsp) ir suaugusių pacientų su periodinis ir/arba metastazavusio dfsp kurie negali gauti chirurgija. ,, suaugusiųjų ir vaikų pacientams, veiksmingumą imatinib 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 imatinib pacientams, sergantiems vni/mpl, susijusių su pdgfr genų vėl priemonės yra labai ribotos. nėra kontroliuojamų tyrimų rodo, klinikinės naudos ar padidėjo išgyvenamumas šių ligų.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

eli lilly nederland b.v. - abemaciclib - krūties navikai - antinavikiniai vaistai - early breast cancerverzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence (see section 5. in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist. advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

Europos Sąjunga - lietuvių - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumabas - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antinavikiniai vaistai - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - imunosupresantai - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - krūties navikai - antinavikiniai vaistai - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Europos Sąjunga - lietuvių - 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.

Europos Sąjunga - lietuvių - 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. .

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

elanco gmbh - gyvi nepa patogūs escherichia coli o141: k94 (f18ac) ir o8: k87 (f4ac). - immunologicals for suidae, live bacterial vaccines - kiaulės - kiaulėms nuo 18 dienų aktyviai imunizuoti nuo enterotoksigeninės f4-teigiamos ir f18-teigiamos escherichia coli, siekiant sumažinti vidutinio sunkumo ir sunkią po nujunkymo e. coli diarėja (pwd) užsikrėtusioms kiaulėms ir sumažina enterotoksigeninio f4-teigiamo ir f18-teigiamo e išsiskyrimą išmatose.. coli užkrėstų kiaulės.

Europos Sąjunga - lietuvių - 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.