Unione Europea - italiano - EMA (European Medicines Agency)

gilead sciences ireland uc - sacituzumab govitecan - breast neoplasms; triple negative breast neoplasms - agenti antineoplastici - trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mtnbc) who have received two or more prior systemic therapies, including at least one of them for advanced disease.

Unione Europea - italiano - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrosi cistica - altri prodotti per il sistema respiratorio - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 e 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 e 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Italia - italiano - Ministero della Salute

santiveri sa -

Unione Europea - italiano - EMA (European Medicines Agency)

immunocore ireland limited - tebentafusp - uveal neoplasms - agenti antineoplastici - kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (hla)-a*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Unione Europea - italiano - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - immunosoppressori - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

Unione Europea - italiano - EMA (European Medicines Agency)

les laboratoires servier - trifluridina, tipiracil hydrochloride - neoplasie colorettali - agenti antineoplastici - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Unione Europea - italiano - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - agenti antineoplastici - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Unione Europea - italiano - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - neoplasie al seno - agenti antineoplastici - 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.

Unione Europea - italiano - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - carcinoma, polmone non a piccole cellule - agenti antineoplastici - 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.

Unione Europea - italiano - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - linagliptin - diabete mellito, tipo 2 - farmaci usati nel diabete - trajenta è indicato nel trattamento del diabete mellito di tipo 2 per migliorare il controllo glicemico negli adulti:come monotherapyin pazienti non adeguatamente controllati con la dieta e l'esercizio fisico da soli e per i quali metformina è inappropriato a causa di intolleranza o controindicazione a causa di insufficienza renale. come combinazione therapyin combinazione con metformina quando dieta ed esercizio fisico più metformina da sola non forniscono un adeguato controllo glicemico. in combinazione con una sulfonilurea e metformina quando dieta ed esercizio fisico plus duplice terapia con questi farmaci non forniscono un adeguato controllo glicemico. in combinazione con insulina, con o senza metformina, quando questo regime da solo, con la dieta e l'esercizio fisico, non forniscono un adeguato controllo glicemico.