Europäische Union - Deutsch - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus erythematodes, systemisch - immunsuppressiva - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.

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

astrazeneca ag - anifrolumabum - konzentrat zur herstellung einer infusionslösung - anifrolumabum 300 mg, histidinum, histidini hydrochloridum monohydricum, lysini hydrochloridum, trehalosum dihydricum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 2 ml. - systemischer lupus erythematodes (sle) - biotechnologika

Europäische Union - Deutsch - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - karzinom, nicht kleinzellige lunge - antineoplastische und immunmodulierende mittel, monoklonale antikörper - nivolumab bms ist indiziert zur behandlung von lokal fortgeschrittenem oder metastasiertem plattenepithelkarzinom nicht-kleinzelligem lungenkrebs (nsclc) nach vorheriger chemotherapie bei erwachsenen.

Europäische Union - Deutsch - 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 - antineoplastische mittel - 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.

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

bristol-myers squibb sa - relatlimabum, nivolumabum - konzentrat zur herstellung einer infusionslösung - relatlimabum 80 mg, nivolumabum 240 mg, histidinum, histidini hydrochloridum monohydricum, saccharum, polysorbatum 80, acidum penteticum, aqua ad iniectabile ad solutionem pro 20 ml. - fortgeschrittenes melanom - biotechnologika

Europäische Union - Deutsch - EMA (European Medicines Agency)

sanofi winthrop industrie - alirocumab - dyslipidemien - lipidmodifizierende mittel - primäre hypercholesterinämie und gemischte dyslipidaemiapraluent ist indiziert bei erwachsenen mit primärer hypercholesterinämie (heterozygote familiäre und nicht familiäre) oder gemischter dyslipidämie, als ergänzung zu diät:in kombination mit einem statin oder ein statin mit anderen lipid-senkende therapien in patienten, die nicht in der lage zu erreichen, ldl-c-ziele mit der maximal tolerierten dosis von statin oder alleine oder in kombination mit anderen lipidsenkenden therapien bei patienten, die statin-unverträglichkeit oder bei denen ein statin kontraindiziert ist. etablierten atherosklerotischen herz-kreislauf-erkrankungen praluent ist indiziert bei erwachsenen mit etablierten atherosklerotischen herz-kreislauf-erkrankung zu reduzieren, herz-kreislauf-risiko durch die senkung der ldl-c-spiegel, in ergänzung der korrektur anderer risikofaktoren:in kombination mit der maximal tolerierten dosis von statin mit oder ohne anderen lipid-senkende therapien oder allein oder in kombination mit anderen lipidsenkenden therapien bei patienten, die statin-unverträglichkeit oder bei denen ein statin kontraindiziert ist. für die ergebnisse der studie hinsichtlich der auswirkungen auf den ldl-c -, herz-kreislauf-ereignisse und die bevölkerung untersucht, siehe kapitel 5,.

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

sanofi-aventis (suisse) sa - alirocumabum - lösung zur injektion in fertigspritze - solution: alirocumabum 75 mg, histidini hydrochloridum monohydricum, histidinum, saccharum, polysorbatum 20, aqua ad iniectabile ad solutionem pro 1 ml. - lipidsenker - biotechnologika

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

sanofi-aventis (suisse) sa - alirocumabum - lösung zur injektion in fertigspritze - solution: alirocumabum 150 mg, histidini hydrochloridum monohydricum, histidinum, saccharum, polysorbatum 20, aqua ad iniectabile ad solutionem pro 1 ml. - lipidsenker - biotechnologika

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

sanofi-aventis (suisse) sa - alirocumabum - lösung zur injektion in einem kugelschreiber ausgefüllt - solution: alirocumabum 75 mg, histidini hydrochloridum monohydricum, histidinum, saccharum, polysorbatum 20, aqua ad iniectabile ad solutionem pro 1 ml. - lipidsenker - biotechnologika

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

sanofi-aventis (suisse) sa - alirocumabum - lösung zur injektion in einem kugelschreiber ausgefüllt - solution: alirocumabum 150 mg, histidini hydrochloridum monohydricum, histidinum, saccharum, polysorbatum 20, aqua ad iniectabile ad solutionem pro 1 ml. - lipidsenker - biotechnologika