Europäische Union - Deutsch - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - asthma - medikamente für obstruktive atemwegserkrankungen, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

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

glaxosmithkline ag - mepolizumabum - injektionslösung im fertigpen - mepolizumabum 100 mg, saccharum, dinatrii phosphas heptahydricus, acidum citricum monohydricum, polysorbatum 80 dinatrii edetas, aqua ad iniectabile q.s. ad solutionem pro 1.0 ml. - eosinophiles asthma, egpa, crswnp, hes - biotechnologika

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

glaxosmithkline ag - mepolizumabum - injektionslösung in der fertigspritze - mepolizumabum 100 mg, saccharum, dinatrii phosphas heptahydricus, acidum citricum monohydricum, polysorbatum 80 dinatrii edetas, aqua ad iniectabile q.s. ad solutionem pro 1.0 ml. - eosinophiles asthma, egpa, crswnp, hes - biotechnologika

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

glaxosmithkline ag - mepolizumabum - lyophilisat zur herstellung einer injektionslösung - praeparatio cryodesiccata: mepolizumabum 100 mg, saccharum, dinatrii phosphas heptahydricus corresp. natrium 1.5-2 mg, polysorbatum 80, acidum hydrochloricum q.s. ad ph pro vitro. - zusatztherapie bei schwerem eosinophilem asthma, zusatztherapie bei erwachsenen mit egpa - biotechnologika

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

takeda pharma ag - vedolizumabum - injektionslösung in einem fertigpen - vedolizumabum 108 mg, acidum citricum monohydricum, natrii citras dihydricus corresp. natrium 1.11 mg, histidinum, histidini hydrochloridum monohydricum, arginini hydrochloridum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 0.68 ml. - colitis ulcerosa, morbus crohn - biotechnologika

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

takeda pharma ag - vedolizumabum - injektionslösung in einer fertigspritze - vedolizumabum 108 mg, acidum citricum monohydricum, natrii citras dihydricus corresp. natrium 1.11 mg, histidinum, histidini hydrochloridum monohydricum, arginini hydrochloridum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 0.68 ml. - colitis ulcerosa, morbus crohn - biotechnologika

Europäische Union - Deutsch - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hämoglobinurie, paroxysmal - immunsuppressiva - soliris ist indiziert bei erwachsenen und kindern zur behandlung von:paroxysmale nächtliche haemoglobinuria (pnh). klinischer nutzen ist nachgewiesen bei patienten mit hämolyse mit klinischen symptom(s) indikativ von hoher krankheitsaktivität unabhängig von der transfusion geschichte (siehe abschnitt 5. atypische hämolytisch-urämisches syndrom (ahus). soliris ist indiziert bei erwachsenen zur behandlung von:refraktären generalisierten myasthenia gravis (gmg) in patienten, die anti-acetylcholin-rezeptor (achr) antikörper-positiv (siehe abschnitt 5. neuromyelitis optica-spektrum-störung (nmosd) bei patienten, die anti-aquaporin-4 (aqp4) antikörper-positiven mit einem schubförmigen verlauf der erkrankung.

Europäische Union - Deutsch - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektive immunsuppressiva - colitis colitisentyvio ist indiziert für die behandlung von erwachsenen patienten mit mittelschwerer bis schwerer aktiver colitis ulcerosa, die unzureichend mit, verloren, antwort, oder waren intolerant entweder konventionelle therapie oder tumor-nekrose-faktor alpha (tnfa) - antagonisten. morbus crohn diseaseentyvio ist indiziert für die behandlung von erwachsenen patienten mit mäßig bis schwer aktivem morbus crohn, die haben eine unzureichende antwort mit, verloren, antwort, oder waren intolerant entweder konventionelle therapie oder tumor-nekrose-faktor alpha (tnfa) - antagonisten. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Europäische Union - Deutsch - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hämoglobinurie, paroxysmal - immunsuppressiva - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). klinischer nutzen ist nachgewiesen bei patienten mit hämolyse mit klinischen symptom(s) indikativ von hoher krankheitsaktivität unabhängig von der transfusion geschichte (siehe abschnitt 5.

Europäische Union - Deutsch - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastische mittel - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. patienten mit egfr-oder alk-positiven tumor mutationen sollten auch erhalten haben gezielte therapie vor erhalt keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.