União Europeia - alemão - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - karzinom, nicht kleinzellige lunge - andere antineoplastische wirkstoffe, die protein-kinase-inhibitoren - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Suíça - alemão - Swissmedic (Swiss Agency for Therapeutic Products)

baxter ag - fibrinogenum humanum, faktor xiii, aprotininum syntheticum, thrombinum humanum - 2 fertigspritzen - i) kleberprotein-lösung gefroren: fibrinogenum humanum 72-110 mg, factor xiii 0.6-10 u., aprotininum syntheticum 2250-3750 u., albuminum humanum, histidinum, nicotinamidum, polysorbatum 80, natrii citras dihydricus, aqua ad iniectabile, q.s. ad solutionem pro 1 ml. ii) thrombin-lösung gefroren: thrombinum humanum 400-625 u.i., albuminum humanum, calcii chloridum dihydricum, natrii chloridum, aqua ad iniectabile, q.s. ad solutionem pro 1 ml. - gewebekleber und adjuvante blutstillung bei operationen; unterstützung der wundheilung - blutprodukte

Suíça - alemão - Swissmedic (Swiss Agency for Therapeutic Products)

baxter ag - fibrinogenum humanum, faktor xiii, aprotininum syntheticum, thrombinum humanum - 2 fertigspritzen - i) kleberprotein-lösung gefroren: fibrinogenum humanum 144-220 mg, factor xiii 1.2-20 u., aprotininum syntheticum 4500-7500 u., albuminum humanum, histidinum, nicotinamidum, polysorbatum 80, natrii citras dihydricus, aqua ad iniectabile q.s. ad solutionem pro 2 ml. ii) thrombin-lösung gefroren: thrombinum humanum 800-1250 u.i., albuminum humanum, calcii chloridum dihydricum, natrii chloridum, aqua ad iniectabile, q.s. ad solutionem pro 2 ml. - gewebekleber und adjuvante blutstillung bei operationen; unterstützung der wundheilung - blutprodukte

Suíça - alemão - Swissmedic (Swiss Agency for Therapeutic Products)

baxter ag - fibrinogenum humanum, faktor xiii, aprotininum, thrombinum humanum - 2 fertigspritzen - i) kleberprotein-lösung gefroren: fibrinogenum humanum 72-110 mg/ml, factor xiii 0.6-10 u./ml, aprotininum 2250-3750 u./ml, albuminum humanum, histidinum, nicotinamidum, polysorbatum 80, natrii citras dihydricus, aqua ad iniectabile, q.s. ad solutionem pro 5 ml. ii) thrombin-lösung gefroren: thrombinum humanum 400-625 u./ml, albuminum humanum, calcii chloridum dihydricum, natrii chloridum, aqua ad iniectabile, q.s. ad solutionem pro 5 ml. - gewebekleber und adjuvante blutstillung bei operationen; unterstützung der wundheilung - blutprodukte

Alemanha - alemão - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

onkovis gmbh (8111905) - imatinibmesilat - hartkapsel - teil 1 - hartkapsel; imatinibmesilat (30739) 239 milligramm

Bélgica - alemão - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxalta innovations - faktor-viii-inhibitor-bypassing-aktivität - pulver und lösungsmittel zur herstellung einer injektionslösung - 500 u - faktor-viii-inhibitor-bypassing-aktivität 500 iu - factor viii inhibitor bypassing activity

Bélgica - alemão - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxalta innovations - faktor-viii-inhibitor-bypassing-aktivität - pulver und lösungsmittel zur herstellung einer injektionslösung - 1000 u - faktor-viii-inhibitor-bypassing-aktivität 1000 iu - factor viii inhibitor bypassing activity

União Europeia - alemão - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinale stromatumoren - andere antineoplastische wirkstoffe, die protein-kinase-inhibitoren - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

União Europeia - alemão - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastische mittel - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. weitere informationen zum status des humanen epidermalen wachstumsfaktor-rezeptors 2 (her2) finden sie in abschnitt 5. 1 of the smpc. aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. weitere informationen zum her2-status finden sie in abschnitt 5. 1 of the smpc. aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. 1 of the smpc). aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. 1 of the smpc). aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5. 1 of the smpc).

União Europeia - alemão - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastische mittel - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. weitere informationen zum status des humanen epidermalen wachstumsfaktor-rezeptors 2 (her2) finden sie in abschnitt 5. onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with onbevzi in combination with capecitabine. weitere informationen zum her2-status finden sie in abschnitt 5. onbevzi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.