Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

takeda pharma a/s - azilsartan medoxomil - hipertenzija - renino ir angiotenzino sistemos veikiantys vaistai - ipreziv skirtas suaugusiųjų pirminės arterinės hipertenzijos gydymas.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

alexion europe sas - sebelipazė alfa - lipidų metabolizmas, įgimtos klaidos - kiti virškinimo trakto ir metabolizmo produktus, - kanuma yra skiriama ilgalaikėje fermentų pakaitinėje terapijoje (ert) visų amžiaus pacientų, sergančių lizosomų rūgšties lipazės (lal) trūkumu.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinurija, paroksizminis - imunosupresantai - soliris yra nurodyta suaugusiųjų ir vaikų gydymas:paroxysmal nakties haemoglobinuria (pnh). Įrodymų, kad klinikinė nauda yra įrodyta, pacientams, sergantiems haemolysis su klinikinis simptomas(s) rodo aukštą ligos aktyvumo, nepriklausomai nuo perpylimo istorija (žr. skyrių 5. netipiškas hemolizinės uremijos sindromu (ahus). soliris yra nurodyta suaugusiųjų gydymas:ugniai apibendrintas myasthenia miastenija (gmg) pacientams, kurie yra anti-acetilcholino receptorius (achr) antikūnų-teigiamas (žr. skyrių 5. neuromyelitis optica spektro sutrikimas (nmosd) pacientams, kurie yra anti-aquaporin-4 (aqp4) antikūnų-teigiami, ir grįžtamoji žinoma liga.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - nalaksono hidrochlorido dihidratas - opioidų sutrikimai - visi kiti gydomieji produktai - nyxoid yra skirtas skubiam gydymui, kai žinoma arba įtariamas opioidų perdozavimas yra neatidėliotinas, kaip pasireiškia kvėpavimo ir (arba) centrinės nervų sistemos depresija ne medicinos ir sveikatos priežiūros įstaigose. nyxoid is indicated in adults and adolescents aged 14 years and over. nyxoid is not a substitute for emergency medical care.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastimas - neutropenija - immunostimulants, - sumažinti trukmė neutropenia ir sergamumas febrilines neutropenia dėl chemoterapijos.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurija, paroksizminis - selektyvūs imunosupresantai - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastimas - neutropenija - immunostimulants, - neutropenija ir febrili neutropenija sergantiems suaugusiesiems pasireiškimo trukmės mažinimas pacientams, kurių onkologinės ligos (išskyrus lėtinį mieloidinę leukemiją ir mielodisplazinį sindromą).

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)

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leukemija, mieloidas - antineoplastic agents, protein kinase inhibitors - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (aml) that is flt3-itd positive.