Unjoni Ewropea - Taljan - 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.

Unjoni Ewropea - Taljan - EMA (European Medicines Agency)

recordati netherlands b.v. - dinutuximab beta - neuroblastoma - agenti antineoplastici - qarziba è indicato per il trattamento di ad alto rischio di neuroblastoma in pazienti di età compresa tra 12 mesi e di cui sopra, che hanno in precedenza ricevuto chemioterapia di induzione e ha raggiunto almeno una risposta parziale, seguita da terapia mieloablativa e trapianto di cellule staminali, così come i pazienti con storia di recidiva o refrattaria neuroblastoma, con o senza la presenza di malattia residua. prima del trattamento del neuroblastoma recidivante, qualsiasi malattia in atto attivamente deve essere stabilizzata con altre misure idonee. in pazienti con una storia di recidivato/refrattario e di malattia in pazienti che non hanno ottenuto una risposta completa dopo terapia di prima linea, qarziba dovrebbe essere combinato con interleuchina 2 (il 2).

Unjoni Ewropea - Taljan - EMA (European Medicines Agency)

astrazeneca ab - ticagrelor - peripheral vascular diseases; acute coronary syndrome - agenti antitrombotici - possia, in co-somministrata con acido acetilsalicilico (asa), è indicato per la prevenzione di eventi aterotrombotici in pazienti adulti con sindrome coronarica acuta (angina instabile, infarto miocardico non-st-altezza [nstemi] o sopraslivellamento infarto miocardico [stemi]); compresi i pazienti diretti medicamente e coloro che sono riusciti con intervento coronarico percutaneo (pci) o by-pass coronarico (cabg).

Unjoni Ewropea - Taljan - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren, amlodipina, hydrochlorothiazide - ipertensione - sistema cardiovascolare - rasitrio è indicato per il trattamento dell'ipertensione essenziale come terapia sostitutiva in pazienti adulti in cui la pressione arteriosa è adeguatamente controllata la combinazione di aliskiren, amlodipina e idroclorotiazide somministrati contemporaneamente alla stessa dose livello come nella combinazione.

Unjoni Ewropea - Taljan - EMA (European Medicines Agency)

sanofi winthrop industrie - sarilumab - artrite, reumatoide - immunosoppressori - kevzara in combinazione con metotressato (mtx) è indicato per il trattamento di moderatamente a gravemente attiva l'artrite reumatoide (ra) in pazienti adulti che abbiano risposto adeguatamente a, o che sono intolleranti ad uno o più di modificazione anti-reumatica di malattia farmaci (dmard). kevzara può essere somministrato in monoterapia in caso di intolleranza a mtx o quando il trattamento con mtx è inappropriato.

Unjoni Ewropea - Taljan - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - agenti antineoplastici - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Unjoni Ewropea - Taljan - EMA (European Medicines Agency)

cis bio international - ioflupane (123l) - radionuclide imaging; dementia; movement disorders - radiofarmaci diagnostici - questo medicinale è solo per uso diagnostico. striascan è indicato per la rilevazione della perdita funzionale del neurone dopaminergico terminali nello striato:pazienti adulti clinicamente incerto parkinson sindromi che, per esempio, ai primi sintomi, al fine di contribuire a differenziare il tremore essenziale da parkinson sindromi correlate per idiopatica di parkinson, atrofia multisistemica e progressiva paralisi sopranucleare. striascan è in grado di discriminare tra il morbo di parkinson, atrofia multisistemica e progressiva paralisi sopranucleare. nei pazienti adulti, per aiutare a differenziare probabile demenza con corpi di lewy dal morbo di alzheimer. striascan è in grado di discriminare tra demenza con corpi di lewy malattia di parkinson e la demenza.

Unjoni Ewropea - Taljan - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - agenti antineoplastici - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Unjoni Ewropea - Taljan - EMA (European Medicines Agency)

ecuphar nv - enflicoxib - prodotti antinfiammatori e antireumatici - cani - for the treatment of pain and inflammation associated with osteoarthritis (or degenerative joint disease) in dogs.

Unjoni Ewropea - Taljan - EMA (European Medicines Agency)

pinax pharma gmbh - ioflupane (123i) - radionuclide imaging; dementia; movement disorders - radiofarmaci diagnostici - questo medicinale è solo per uso diagnostico. celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:in adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic parkinson’s disease, multiple system atrophy and progressive supranuclear palsy.  celsunax is unable to discriminate between parkinson's disease, multiple system atrophy and progressive supranuclear palsy. nei pazienti adulti, per aiutare a differenziare probabile demenza con corpi di lewy dal morbo di alzheimer.  celsunax is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.