الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

stemline therapeutics b.v. - selinexor - majloma multipla - aġenti antineoplastiċi - nexpovio is indicatedin combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirali għal użu sistemiku - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 u 5. tecovirimat siga should be used in accordance with official recommendations.

الاتحاد الأوروبي - المالطية - 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.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

idorsia pharmaceuticals deutschland gmbh - daridorexant hydrochloride - sleep inizjattiva u maintenance disorders - psikolettiċi - quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolactone - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 u 5.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

stemline therapeutics b.v. - elacestrant - neoplażmi tas-sider - terapija endokrinali - orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (er) positive, her2-negative, locally advanced or metastatic breast cancer with an activating esr1 mutation who have disease progression following at least one line of endocrine therapy including a cdk 4/6 inhibitor.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

proveca pharma limited - enalapril (maleate) - insuffiċjenza tal-qalb - aġenti li jaġixxu fuq is-sistema renin-angiotensin - treatment of heart failure.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

astellas pharma europe bv - tacrolimus - rifjut ta 'graft - immunosoppressanti - profilassi tar-rifjut tat-trapjanti f'riċevituri ta 'l-alloġib tal-kliewi jew tal-fwied adulti. kura ta 'rifjut tal-allograft reżistenti għat-trattament ma' prodotti mediċinali immunosoppressivi oħra f'pazjenti adulti.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - aġenti antineoplastiċi - l-ormon tat-riċettur pożittiva tas-sider avvanzat cancerafinitor huwa indikat għall-kura ta 'l-ormon tat-riċettur-pożittivi, her2/neu negattivi għall-kanċer tas-sider avvanzat, f'kombinazzjoni ma exemestane, fil-nisa wara l-menopawsa mingħajr sintomatika vixxerali-marda wara l-rikorrenza jew l-progressjoni wara mediċini mhux sterojdi ta' inibitur aromatase. newroendokrinika tumuri tal-frixa originafinitor huwa indikat għall-kura ta li ma jistgħax jitneħħa kirurġikament, jew li mmetastatizza, sew jew moderatament differenzjati newroendokrinika tumuri tal-frixa-oriġini fl-adulti bil-marda progressiva. newroendokrinika tumuri tal-gastro-intestinali jew tal-pulmun originafinitor huwa indikat għall-kura ta li ma jistgħax jitneħħa kirurġikament, jew li mmetastatizza, differenzjat tajjeb (grad 1 jew ta ' grad 2) mhux funzjonali newroendokrinika tumuri tal-gastro-intestinali jew tal-pulmun-oriġini fl-adulti bil-marda progressiva. renali taċ-ċelluli carcinomaafinitor huwa indikat għall-kura ta ' pazjenti b'indeboliment avanzat tal-karċinoma taċ-ċellola, li l-marda tagħhom mexa fuq jew wara l-kura bil-vegf-terapija fil-mira.

الاتحاد الأوروبي - المالطية - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - tipranavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - aptivus, mogħti flimkien ma 'doża baxxa ta' ritonavir, huwa indikat għall-kombinazzjoni antiretrovirali tat-trattament ta ' l-hiv-1 infezzjoni fil ħafna ttrattati minn qabel adulti u adolexxenti minn 12-il sena jew akbar fl-età bil-virus reżistenti għall-inibituri ta'proteasi multipliċi. aptivus għandu jintuża biss bħala parti minn attiva antiretrovirali kombinata-dożaġġ f'pazjenti bl-ebda għażliet terapewtiċi oħra. din l-indikazzjoni hija bbażata fuq ir-riżultati ta 'żewġ studji ta' fażi iii, magħmul f'ħafna ttrattati minn qabel pazjenti adulti (numru medjan ta '12-il qabel ma' aġenti antiretrovirali) bil-virus reżistenti għall-inibituri tal-protease u tal-fażi ii studju li investiga l-farmakokinetika, is-sigurtà u l-effikaċja ta ' aptivus fil-aktar li esperjenzaw it-trattament-pazjenti adolexxenti minn 12 sa 18-il sena. id-deċiżjoni li jinbeda it-trattament b'aptivus, mogħti flimkien ma 'doża baxxa ta' ritonavir, għandha tingħata konsiderazzjoni kbira lill-istorja tat-trattament tal-pazjent individwali u l-mudelli ta 'tibdiliet ġenetiċi assocjati ma' mediċini differenti. testijiet ġenotipiċi u finotipiċi (fejn disponibbli) u l-istorja tat-trattament għandhom jiggwidaw l-użu ta ' aptivus. il-bidu tat-trattament għandu jqis il-kombinazzjonijiet ta 'mutazzjonijiet li jistgħu jikkaġunaw impatt ta' rispons nagattiv għal aptivus, mogħti flimkien ma 'doża baxxa ta' ritonavir.