欧州連合 - イタリア語 - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psoriasi - immunosoppressori - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

欧州連合 - イタリア語 - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - agenti antineoplastici - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

欧州連合 - イタリア語 - EMA (European Medicines Agency)

roche registration gmbh  - pralsetinib - carcinoma, polmone non a piccole cellule - agenti antineoplastici - gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (ret) fusion-positive advanced non-small cell lung cancer (nsclc) not previously treated with a ret inhibitor.

欧州連合 - イタリア語 - EMA (European Medicines Agency)

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - agenti antineoplastici - columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl), after two or more lines of systemic therapy.

欧州連合 - イタリア語 - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - immunosoppressori - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

欧州連合 - イタリア語 - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - linfoma, follicolare - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies.

欧州連合 - イタリア語 - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. l'effetto di imatinib sull'esito del trapianto di midollo osseo non è stata determinata. imatinib actavis is indicated for: , 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. l'esperienza con imatinib in pazienti con mds/mpd associate a riarrangiamenti del gene pdgfr è molto limitata. non ci sono studi clinici controllati che dimostrano un beneficio clinico o un aumento della sopravvivenza per queste malattie.

欧州連合 - イタリア語 - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin - diabete mellito, tipo 2 - farmaci usati nel diabete - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 e 5.

欧州連合 - イタリア語 - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - neoplasie ovariche - agenti antineoplastici - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. rubraca è indicato come monoterapia per il trattamento di mantenimento di pazienti adulti con platino-sensibile di una recidiva di alta qualità epiteliali dell'ovaio, tube di falloppio, o cancro peritoneale primario che la risposta (completa o parziale) alla chemioterapia a base di platino.

欧州連合 - イタリア語 - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - farmaci usati nel diabete - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 e 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.