Nisso Chemical Europe GmbH - leitarniðurstöður

Evrópusambandið - ítalska - EMA (European Medicines Agency)

nustendi

daiichi sankyo europe gmbh - bempedoic acido, ezetimibe - hypercholesterolemia; dyslipidemias - agenti modificanti i lipidi - nustendi è indicato in pazienti adulti con ipercolesterolemia primaria (eterozigote familiare e non-familiare) o dislipidemia mista, in aggiunta alla dieta:in combinazione con una statina in pazienti non in grado di raggiungere ldl-c obiettivi con la dose massima tollerata di una statina, oltre a ezetimibealone in pazienti che sono statina-intolleranti o per cui una statina è controindicato, e sono in grado di raggiungere ldl-c gli obiettivi di ezetimibe da solo,in pazienti già trattati con la combinazione di bempedoic acido e ezetimibe in compresse separate con o senza una statina.

Evrópusambandið - ítalska - EMA (European Medicines Agency)

enhertu

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.

Evrópusambandið - ítalska - EMA (European Medicines Agency)

vanflyta

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leucemia, mieloide - 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.