欧州連合 - マルタ語 - EMA (European Medicines Agency)

advanz pharma limited - obeticholic acid - Ċirrożi tal-fwied, biliary - terapija biljari u tal-fwied - ocaliva huwa indikat għat-trattament ta ' l-cholangitis bilarju primarja (magħrufa wkoll bħala primarji biliary cirrhosis) flimkien ma ' l-aċidu ursodeoxycholic (udca) fl-adulti bi tweġiba inadegwata biex udca jew bħala monotherapy fl-adulti ma jistax jittollera l-udca.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - teduglutide - sindromi ta 'malassorbiment - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - revestive huwa indikat għall-kura ta 'pazjenti ta' età ta 'sena u aktar minn sindromu qosra tal-musrana (sbs). il-pazjenti għandhom ikunu stabbli wara perijodu ta 'adattament intestinali wara l-operazzjoni. revestive huwa indikat għall-kura tal-pazjenti ta'bejn l-1 sena u ' l fuq bil-qosor tal-musrana sindromu. il-pazjenti għandhom ikunu stabbli wara perijodu ta 'adattament intestinali wara l-operazzjoni.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - entecavir - epatite b, kronika - antivirali għal użu sistemiku - entecavir accord is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. , mard tal-fwied dekompensat. , kemm għall-kkumpensati u mard tal-fwied dikumpensat, din l-indikazzjoni hija bbażata fuq tagħrif minn provi kliniċi f'pazjenti li huma nucleoside naïve b'hbeag pożittiv u hbeag negattiv li jaqbadhom infezzjoni hbv. fir-rigward ta 'pazjenti b'epatite b refrattarja għal lamivudine. entecavir-ftehim huwa indikat ukoll għat-trattament ta ' infezzjoni hbv kronika nucleoside naïve pazjenti pedjatriċi minn 2 sa.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase alkpositive advanced nsclc previously treated with crizotinib.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkulożi, b'resistema multidrug - antimikobatterjali - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - thiotepa - hematopoietic stem cell transplantation; neoplasms - aġenti antineoplastiċi - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - aġenti antineoplastiċi - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - relugolix - neoplasmi prostatiċi - terapija endokrinali - orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - tolvaptan - sindromu adh inappropriate - id-dijuretiċi, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).

欧州連合 - マルタ語 - EMA (European Medicines Agency)

viatris healthcare limited - imiquimod - condylomata acuminata; keratosis; keratosis, actinic; carcinoma, basal cell - antibijotiċi u kimoterapewtiċi għal użu dermatoloġiku - imiquimod cream is indicated for the topical treatment of :external genital and perianal warts (condylomata acuminata) in adults. small superficial basal cell carcinomas (sbccs) in adults. clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (aks) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.