Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

pharmathen s.a. - ibandrono rūgštis - hypercalcemia; fractures, bone; neoplasm metastasis; breast neoplasms - narkotikai kaulų ligų gydymui - concentrate for solution for infusion prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. gydymo auglio sukeltas hypercalcaemia su arba be metastazių. film-coated tablets prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

theravia - cholinė rūgštis - digestive system diseases; metabolism, inborn errors - tulžies rūgštys ir jų dariniai - orphacol yra skirtas gydyti įgimtus pirminės tulžies rūgšties sintezės 3β-hidroksi-Δ5-c27-steroidų oksidoreduktazės negalios ar Δ4-3-oxosteroid-5β-reduktazės trūkumas kūdikiams, vaikams ir paaugliams nuo vieno mėnesio iki 18 metų ir suaugusiems.

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)

gedeon richter ltd  - ulipristalio acetatas - leiomyoma - lytiniai hormonai ir moduliatoriai lytinių organų sistemos, - ulipristalio acetatas skirtas priešlaikiniam gimdos fibrozės simptomų vidutinio sunkumo ar sunkių simptomų gydymui suaugusių reprodukcinio amžiaus moterims. ulipristal acetatas yra nurodyta su pertrūkiais gydant vidutinio sunkumo ir sunkių simptomų gimdos fibroma suaugusiųjų vaisingo amžiaus moterys.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - hipercholesterolemija - lipidą keičiančios medžiagos - lojuxta skiriamas kaip papildoma low‑fat dietos ir kitais lipid‑lowering vaistiniais preparatais arba be žemo tankio lipoproteinų (mtl) aferezės suaugusių pacientų, sergančių homozigotine šeimine hipercholesterolemija (hŠh). genetiniai patvirtinimo hofh turėtų būti gauti, kai tik įmanoma. kitų formų pirminių hyperlipoproteinaemia ir antrinės priežastys hypercholesterolaemia e. nephrotic sindromas, hipotireozė), turi būti atmesti.

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)

eli lilly nederland b.v. - baricitinib - artritas, reumatas - imunosupresantai - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumianetą galima vartoti kaip monoterapiją arba kartu su metotreksatu. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

gedeon richter plc. - ulipristalio acetatas - leiomyoma - lytiniai hormonai ir moduliatoriai lytinių organų sistemos, - ulipristal acetatas yra nurodyta už vieną gydymo kursą, priešoperacinis gydymas, vidutinio sunkumo ir sunkių simptomų gimdos fibroma suaugusiųjų vaisingo amžiaus moterys. ulipristal acetatas yra nurodyta su pertrūkiais gydant vidutinio sunkumo ir sunkių simptomų gimdos fibroma suaugusiųjų vaisingo amžiaus moterų, kurie nėra tinkami chirurgija.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - upadacitinib - artritas, reumatas - imunosupresantai - rheumatoid arthritisrinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (dmards). rinvoq may be used as monotherapy or in combination with methotrexate. psoriatic arthritisrinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more dmards. rinvoq may be used as monotherapy or in combination with methotrexate. axial spondyloarthritisnon-radiographic axial spondyloarthritis (nr-axspa)rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri), who have responded inadequately to nonsteroidal anti-inflammatory drugs (nsaids). ankylosing spondylitis (as, radiographic axial spondyloarthritis)rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. atopic dermatitisrinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. ulcerative colitisrinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.  crohn’s diseaserinvoq is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemofilija b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.