Европейски съюз - немски - 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.

Европейски съюз - немски - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastische mittel - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patienten, die einen niedrigen oder sehr niedrigen rückfallrisiko sollten nicht erhalten eine adjuvante behandlung. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. außer bei patienten mit neu diagnostiziertem chronischen phase der cml gibt es keine kontrollierten studien zeigen einen klinischen nutzen oder erhöhte überlebenschancen für diese krankheiten.

Европейски съюз - немски - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - karzinom, nicht kleinzellige lunge - antineoplastische mittel - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Германия - немски - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

novartis pharma gmbh (8011799) - octreotidacetat (1:x) ((mit angaben zum essigsäure-gehalt)) - injektionslösung - octreotidacetat (1:x) ((mit angaben zum essigsäure-gehalt)) (23738) 1,623 milligramm

Германия - немски - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

pfizer pharma gmbh (8075658) - somatropin - pulver und lösungsmittel zur herstellung einer injektionslösung - teil 1 - pulver zur herstellung einer injektionslösung; somatropin (22339) 12 milligramm

Германия - немски - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

pfizer pharma gmbh (8075658) - somatropin - pulver und lösungsmittel zur herstellung einer injektionslösung - teil 1 - pulver zur herstellung einer injektionslösung; somatropin (22339) 5,8 milligramm

Европейски съюз - немски - EMA (European Medicines Agency)

biopartners gmbh - somatropin - wachstum - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners ist indiziert für die substitutionstherapie von endogenem wachstumshormon bei erwachsenen mit wachstumshormonmangel (ghd) im kindes- oder erwachsenenalter. adult-onset: patienten mit ghd im erwachsenenalter sind definiert als patienten mit bekannter hypothalamisch-hypophysär pathologie und mindestens einen weiteren bekannten mangel einer hypophyse hormon ohne prolaktin. diese patienten sollten sich einer einzigen dynamischen tests, um zu diagnostizieren oder auszuschließen, eine ghd. kindheit-auftreten: bei patienten mit childhood-onset isolierten ghd (keine hinweise auf hypothalamus-hypophysen-krankheit oder kraniale bestrahlung), werden zwei dynamische tests sollten durchgeführt werden, nach abschluss des wachstums, außer für diejenigen, die niedrigen insulin-like-growth-faktor-i (igf-i) konzentrationen (< -2 standard-deviation-score (sds)), kann betrachtet werden, für einen test. der cut-off-punkt von den dynamischen test soll streng sein.

Швейцария - немски - Swissmedic (Swiss Agency for Therapeutic Products)

pfizer ag - pegvisomantum - pulver und lösungsmittel zur herstellung einer injektionslösung - praeparatio cryodesiccata: pegvisomantum 10 mg, glycinum, mannitolum, dinatrii phosphas, natrii dihydrogenophosphas monohydricus pro vitro corresp. natrium 0.4 mg. solvens: aqua ad iniectabile 1 ml. - akromegalie - biotechnologika

Швейцария - немски - Swissmedic (Swiss Agency for Therapeutic Products)

pfizer ag - pegvisomantum - pulver und lösungsmittel zur herstellung einer injektionslösung - praeparatio cryodesiccata: pegvisomantum 15 mg, glycinum, mannitolum, dinatrii phosphas, natrii dihydrogenophosphas monohydricus pro vitro corresp. natrium 0.4 mg. solvens: aqua ad iniectabile 1 ml. - akromegalie - biotechnologika

Швейцария - немски - Swissmedic (Swiss Agency for Therapeutic Products)

pfizer ag - pegvisomantum - pulver und lösungsmittel zur herstellung einer injektionslösung - praeparatio cryodesiccata: pegvisomantum 20 mg, glycinum, mannitolum, dinatrii phosphas, natrii dihydrogenophosphas monohydricus pro vitro corresp. natrium 0.4 mg. solvens: aqua ad iniectabile 1 ml. - akromegalie - biotechnologika