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)

orphelia pharma sas - vigabatrin - spasms, infantile; epilepsies, partial - antiepileptics, - kigabeq yra nurodyta kūdikiams ir vaikams nuo 1 mėnesio iki mažiau kaip 7 metų amžiaus:gydymo monotherapy iš infantilus spazmai (west sindromas). gydymas kartu su kitų vaistų nuo epilepsijos vaistus, pacientams, kuriems yra atsparus dalinės epilepsijos (židinio pasireiškė traukuliai) su ar be antrinės apibendrinti, tai yra, kai visų kitų atitinkamų vaistų deriniais, buvo pakankamos, ar nebuvo toleruojamas.

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)

zoetis belgium sa - sevofluranas - anestetikai, bendrojo - dogs; cats - Šunims ir katėms sukelti ir išlaikyti anesteziją.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

amgen europe b.v. - etelcalcetid hydrochloride - hiperparatiroidizmas, antrinis - anti-parathyroid agents, calcium homeostasis - parsabiv skiriamas antrinio hiperparatiroidizmo (shpt) gydymui suaugusiems pacientams, sergantiems lėtinės inkstų ligos (ckd) hemodializės terapija.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

regeneron uk limited - rilonacept - cryopyrin susijusių periodiškai sindromai - imunosupresantai - rilonaceptas regeneron skirtas su kriopirinu susiję periodiniai sindromai (sksps) gydymui su sunkiu ligos simptomai, įskaitant šeiminės šalčio autoimunine sindromo (ŠŠas) ir muckle wells sindromas (mws), suaugusiesiems ir vaikams nuo 12 metų ir vyresnio amžiaus.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

tmc pharma services ltd. - gadofosveset trisodium - magnetinio rezonanso angiografija - kontrasto terpė - Šis vaistas yra skirtas tik diagnostikai. ablavar yra nurodyta priešingai-sustiprinti magnetinio rezonanso angiografija (ce-mra) vizualizacijos, pilvo ar galūnių laivams tik suaugusiems, su įtariama arba žinoma kraujagyslių ligos.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

ferrer internacional s.a. - loksapinas - schizophrenia; bipolar disorder - nervų sistema - adasuvas yra skirtas greitai kontroliuoti silpnai ar vidutinio stiprumo susijaudinimą suaugusiems pacientams, sergantiems šizofrenija ar bipoliniu sutrikimu. pacientams reikėtų reguliariai gauti gydymą iškart po kontrolės ūmaus nerimo simptomai.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

novartis europharm limited - brinzolamido, timololio maleatas - glaucoma, open-angle; ocular hypertension - oftalmologai - suaugusiems pacientams, kuriems yra atvirojo kampo glaukoma arba akių hipertenzija, mažėja intraokulinis slėgis (iop), kuriems monoterapija sukelia nepakankamą stemplės sumažėjimą.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

les laboratoires servier - ivabradino hidrochloridas - angina pectoris; heart failure - Širdies terapijos - simptominis gydymas lėtinės stabilios krūtinės anginos pectorisivabradine fluorouracilu ir simptominis gydymas lėtinės stabilios krūtinės angina, išeminė širdies liga suaugusiesiems normalus sinusinis ritmas ir širdies susitraukimų dažnis ≥ 70 k / min. ivabradine yra nurodyta:suaugusieji negali toleruoti ar su kontraindikacijos naudojant beta-blockersor kartu su beta-blokatorių, pacientams, nepakankamai kontroliuoja optimalų beta-blokatoriaus dozę. gydymo nuo lėtinio širdies failureivabradine yra nurodyta lėtinis širdies nepakankamumas nyha ii-iv klasės, kurių sistolinis funkcijos sutrikimas, sergantiems sinusinio ritmo ir kurių širdies ritmas yra ≥ 75 k / min, kartu su standartine terapija įskaitant beta-blokatorius terapija arba kai beta-blokatorius gydymas yra kontraindikuotinas arba netoleruojami.