الاتحاد الأوروبي - الإيطالية - EMA (European Medicines Agency)

roche registration ltd. - daclizumab - graft rejection; kidney transplantation - immunosoppressori - zenapax è indicato per la profilassi del rigetto acuto nel trapianto renale allogenico di de novo e deve essere utilizzato in concomitanza con un regime immunosoppressivo, inclusi ciclosporina e i corticosteroidi in pazienti che non sono altamente immunizzati.

الاتحاد الأوروبي - الإيطالية - EMA (European Medicines Agency)

roche registration gmbh - ocrelizumab - sclerosi multipla - immunosoppressori - trattamento di pazienti adulti con forme recidivanti di sclerosi multipla (rms) con malattia attiva definita da caratteristiche cliniche o di imaging. trattamento di pazienti adulti con inizio sclerosi multipla progressiva primaria (ppm) in termini di durata di malattia e il livello di disabilità, e con funzioni di imaging caratteristica di attività infiammatoria.

الاتحاد الأوروبي - الإيطالية - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - agenti antineoplastici - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq come monoterapia è indicato per il trattamento di pazienti adulti con carcinoma localmente avanzato o metastatico nsclc dopo una precedente chemioterapia. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq come monoterapia è indicato per il trattamento di pazienti adulti con carcinoma localmente avanzato o metastatico nsclc dopo una precedente chemioterapia. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

الاتحاد الأوروبي - الإيطالية - EMA (European Medicines Agency)

roche registration limited - emicizumab - emofilia a - antiemorragici - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype. hemlibra può essere utilizzato in tutti i gruppi di età.

الاتحاد الأوروبي - الإيطالية - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - linfoma a cellule b - agenti antineoplastici - polivy in combinazione con bendamustine e rituximab è indicato per il trattamento di pazienti adulti con recidivato/refrattario diffuso a grandi cellule b (dlbcl), che non sono candidati per il trapianto di cellule staminali ematopoietiche. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

الاتحاد الأوروبي - الإيطالية - 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.

الاتحاد الأوروبي - الإيطالية - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - influenza, umano - antivirali per uso sistemico - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

الاتحاد الأوروبي - الإيطالية - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - neoplasie al seno - agenti antineoplastici - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

الاتحاد الأوروبي - الإيطالية - EMA (European Medicines Agency)

roche registration gmbh  - risdiplam - atrofia muscolare, spinale - altri farmaci per i disturbi del sistema muscolo-scheletrico - evrysdi is indicated for the treatment of 5q spinal muscular atrophy (sma) in patients with a clinical diagnosis of sma type 1, type 2 or type 3 or with one to four smn2 copies.

الاتحاد الأوروبي - الإيطالية - 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.