Europos Sąjunga - italų - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - cedazuridine, decitabine - leucemia, mieloide - agenti antineoplastici - inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for standard induction chemotherapy.

Europos Sąjunga - italų - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - rene policistico, dominante autosomica - diuretici, - jinarc è indicato per rallentare la progressione di sviluppo di cisti e insufficienza renale della malattia renale policistica dominante autosomica (adpkd) negli adulti con insufficienza renale cronica della fase 1 a 3 all'inizio del trattamento con evidenza di malattia velocemente di progressione.

Europos Sąjunga - italų - EMA (European Medicines Agency)

orexigen therapeutics ireland limited - bupropione cloridrato, naltrexone cloridrato - obesity; overweight - preparazioni antiobesità, escl. prodotti dietetici - mysimba è indicato come coadiuvante di una dieta a basso contenuto calorico e un aumento dell'attività fisica, per la gestione del peso in pazienti adulti (≥18 anni) con un primo indice di massa corporea (bmi)≥ 30 kg/m2 (obesi) o≥ 27 kg/m2 e < 30 kg/m2 (sovrappeso) in presenza di uno o più di peso-correlate co morbilità (e. il diabete di tipo 2, dislipidemia, controllato o di ipertensione)il trattamento con mysimba deve essere interrotto dopo 16 settimane se i pazienti non hanno perso almeno il 5% del loro peso corporeo iniziale.

Europos Sąjunga - italų - EMA (European Medicines Agency)

novartis europharm limited - l'indacaterolo, glycopyrronium bromuro - malattia polmonare, ostruttiva cronica - adrenergici in combinazione con farmaci anticolinergici incl. combinazioni triple con corticosteroidi - xoterna breezhaler è indicato come trattamento broncodilatatore di mantenimento per alleviare i sintomi in pazienti adulti con malattia polmonare ostruttiva cronica (bpco).

Europos Sąjunga - italų - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - agenti antineoplastici - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Europos Sąjunga - italų - EMA (European Medicines Agency)

ptc therapeutics international limited - ataluren - distrofia muscolare, duchenne - altri farmaci per i disturbi del sistema muscolo-scheletrico - translarna è indicato per il trattamento della distrofia muscolare di duchenne derivante da una mutazione nonsenso nel gene della distrofina, in ambulatorio pazienti di età compresa tra 2 anni e più. l'efficacia non è stata dimostrata in pazienti non deambulanti. la presenza di una mutazione di assurdità nel gene della distrofina deve essere determinata da un test genetico.

Europos Sąjunga - italų - EMA (European Medicines Agency)

novartis europharm limited - l'indacaterolo, glycopyrronium bromuro - malattia polmonare, ostruttiva cronica - adrenergici in combinazione con farmaci anticolinergici incl. combinazioni triple con corticosteroidi, farmaci per le malattie respiratorie ostruttive, - ultibro breezhaler è indicato come trattamento broncodilatatore di mantenimento per alleviare i sintomi in pazienti adulti con malattia polmonare ostruttiva cronica (bpco).

Europos Sąjunga - italų - EMA (European Medicines Agency)

novartis europharm limited - glycopyrronium bromuro, indacaterolo maleato - malattia polmonare, ostruttiva cronica - farmaci per le malattie respiratorie ostruttive, - ulunar breezhaler è indicato come trattamento broncodilatatore di mantenimento per alleviare i sintomi in pazienti adulti con malattia polmonare ostruttiva cronica (bpco).

Europos Sąjunga - italų - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - sclerosi multipla recidivante-remittente - immunosoppressori - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Europos Sąjunga - italų - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - immunosoppressori - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).