Deutschland - Deutsch - BVL (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit)

growth technology ltd. - sonstige flüssigkeiten zur unverdünnten anwendung - 3,3 g/l 4-(indol-3-yl)buttersäure (3,92 g/l kalium-salz) - wachstumsregler

Europäische Union - Deutsch - EMA (European Medicines Agency)

ascendis pharma endocrinology division a/s - lonapegsomatropin - growth and development - hormone und analoga der hypophyse und des hypothalamus - growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [ghd]),.

Europäische Union - Deutsch - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - 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 - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma 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. vegzelma 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 vegzelma in combination with capecitabine. weitere informationen zum her2-status finden sie in abschnitt 5. vegzelma, 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 (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, 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. vegzelma, 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 vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, 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. vegzelma, 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.

Europäische Union - Deutsch - EMA (European Medicines Agency)

pfizer europe ma eeig - somatrogon - growth and development - hypophysen-und hypothalamus-hormone und analoga - indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.

Europäische Union - Deutsch - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laron-syndrom - hormone und analoga der hypophyse und des hypothalamus - zur langzeitbehandlung von wachstumsstörungen bei kindern und jugendlichen mit schwerem primärem insulin-like-growth-factor-1-mangel (primäre igfd). schwere primäre igfd ist definiert durch:höhe der standard-deviation-score ≤ -3. 0-und;basal insulin-like growth factor-1 (igf-1) ebenen unterhalb der 2. 5. perzentil für alter und geschlecht und;growth hormone (gh) hinlänglichkeit;ausschluss der sekundären formen des igf-1-mangels wie unterernährung, schilddrüsenunterfunktion oder chronische behandlung mit pharmakologischen dosen von anti-inflammatorischen steroiden. schwere primäre igfd gehören patienten mit mutationen im gh-rezeptor (ghr), post-ghr-signalweg und igf-1-gendefekten; sie sind nicht gh-mangel, und daher kann nicht erwartet werden, angemessen zu reagieren auf exogene gh-behandlung. es wird empfohlen, um die diagnose zu bestätigen, die von der durchführung eines igf-1 generation test,.

Europäische Union - Deutsch - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastische mittel - glivec is indicated for the treatment of , adult 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-pdgfra rearrangement. die wirkung von glivec auf das ergebnis der knochenmark-transplantation ist nicht bestimmt worden. glivec is indicated for: , the 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; die behandlung von erwachsenen patienten mit nicht resezierbarem dermatofibrosarcoma protuberans (dfsp) und erwachsenen patienten mit rezidivierendem und / oder metastasiertem dfsp, die nicht förderfähig sind, für die chirurgie. in erwachsenen und pädiatrischen patienten, die wirksamkeit von glivec basiert auf der hämatologischen und zytogenetischen ansprechraten und das progressionsfreie überleben bei cml, die auf hämatologische und zytogenetische ansprechraten in ph+ all, mds / mpd, auf der hämatologischen ansprechrate in hes / cel und auf objektiven response-raten bei erwachsenen patienten mit inoperablen und / oder metastasierten gist und dfsp und rezidiv-freie überleben in der adjuvanten gist. die erfahrung mit glivec bei patienten mit mds / mpd im zusammenhang mit pdgfr-gen re-arrangements ist sehr begrenzt (siehe abschnitt 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.

Europäische Union - Deutsch - 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.

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

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

Europäische Union - Deutsch - 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.

Europäische Union - Deutsch - 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).