Europäische Union - Deutsch - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastische mittel - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 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 (see sections 4. 4 und 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab 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. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab 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 (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab 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%.

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

bristol-myers squibb sa - ipilimumabum - konzentrat zur herstellung einer infusionslösung - ipilimumabum 50 mg, trometamoli hydrochloridum, natrii chloridum, mannitolum, acidum penteticum, polysorbatum 80, natrii hydroxidum aut acidum hydrochloridum, aqua ad iniectabile q.s. ad solutionem pro 10 ml corresp. natrium 23 mg. - melanom, nierenzellkarzinom, kolorektales karzinom - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

bristol-myers squibb sa - ipilimumabum - konzentrat zur herstellung einer infusionslösung - ipilimumabum 200 mg, trometamoli hydrochloridum, natrii chloridum, mannitolum, acidum penteticum, polysorbatum 80, natrii hydroxidum aut acidum hydrochloridum, aqua ad iniectabile q.s. ad solutionem pro 40 ml corresp. natrium 92 mg. - melanom, nierenzellkarzinom, kolorektales karzinom - biotechnologika