Den europeiske union - norsk - 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 - antineoplastiske midler - 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. for ytterligere informasjon om human epidermal growth factor receptor 2 (her2) status, se avsnitt 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. for ytterligere informasjon om her2-status, se avsnitt 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.

Den europeiske union - norsk - EMA (European Medicines Agency)

eli lilly nederland b.v. - olaratumab - sarkom - antineoplastiske midler - lartruvo angis i kombinasjon med doksorubicin for behandling av voksne pasienter med avansert bløtvev sarkomspesialitet som ikke er mottakelig for helbredende behandling med kirurgi eller strålebehandling, og som har ikke blitt behandlet med doksorubicin (se del 5.

Den europeiske union - norsk - EMA (European Medicines Agency)

amgen europe b.v. - romiplostim - purpura, trombocytopenisk, idiopatisk - antihemoragika - adults:nplate is indicated for the treatment of primary immune thrombocytopenia  (itp) in adult patients who are refractory to other treatments (e. kortikosteroider, immunglobuliner). paediatrics:nplate is indicated for the treatment of chronic primary immune thrombocytopenia (itp) in paediatric patients one year of age and older who are refractory to other treatments (e. kortikosteroider, immunglobuliner).

Den europeiske union - norsk - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - immunsuppressive - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Den europeiske union - norsk - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - idecabtagene vicleucel - multiple myeloma; neoplasms; cancer; neoplasms, plasma cell; hemostatic disorders; vascular diseases; cardiovascular diseases; paraproteinemias; blood protein disorders; hematologic diseases; hemic and lymphatic diseases; hemorrhagic disorders; infectious mononucleosis; lymphoproliferative disorders; immunoproliferative disorders; immune system diseases - antineoplastiske midler - abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Den europeiske union - norsk - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - multippelt myelom - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Den europeiske union - norsk - EMA (European Medicines Agency)

baxalta innovations gmbh - vonicog alfa - von willebrand sykdommer - antihemoragika - veyvondi er indisert hos voksne (18 år og eldre) med genet for von willebrand disease (vwd), når desmopressin (ddavp) behandling alene er ineffektiv eller ikke indisert for behandling av blødning og kirurgisk blødning - forebygging av kirurgisk blødning. veyvondi burde ikke bli brukt i behandlingen av haemophilia en.

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - avatrombopag maleate - trombocytopeni - antihemoragika - doptelet er angitt for behandling av alvorlig trombocytopeni hos voksne pasienter med kronisk leversykdom som er planlagt å gjennomgå en invasiv prosedyre. doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e. kortikosteroider, immunglobuliner).

Den europeiske union - norsk - EMA (European Medicines Agency)

fondazione telethon ets - autologous cd34 + beriket celle brøkdel som inneholder cd34 + celler transduced med retroviral vektor som koder for menneskelig adenosin deaminase (ada) cdna forløp fra menneskelige haematopoietic stammen/stamfar (cd34 +) celler - alvorlig kombinert immundefekt - immunostimulants, - strimvelis er indisert for behandling av pasienter med alvorlig kombinert immunsvikt på grunn av adenosin deaminase mangel (ada-scid), som ingen passende menneskelige leukocytter antigen (hla)-matchet relaterte stamcelleforskningen donor er tilgjengelig (se seksjon 4. 2 og 4.

Den europeiske union - norsk - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; wegener granulomatosis - antineoplastiske midler - ritemvia er angitt i voksne for følgende indikasjoner:non-hodgkins lymfom (nhl) ritemvia er angitt for behandling av tidligere ubehandlede pasienter med stadium iii, iv follicular lymfom i kombinasjon med kjemoterapi. ritemvia vedlikehold behandling er indisert for behandling av follicular lymfom pasienter som responderer på induksjonsbehandling. ritemvia monoterapi er indisert for behandling av pasienter med stadium iii, iv follicular lymfom som er kjemoterapi resistente eller er i sitt andre eller senere tilbakefall etter kjemoterapi. ritemvia er indisert for behandling av pasienter med cd20-positive diffuse store b-celle non hodgkins lymfom i kombinasjon med chop (cyklofosfamid, doxorubicin, vinkristin, prednisolon) kjemoterapi. granulomatosis med polyangiitis og mikroskopiske polyangiitis. ritemvia, i kombinasjon med glukokortikoider, er indikert for induksjon av remisjon hos voksne pasienter med alvorlig, aktiv granulomatosis med polyangiitis (wegener ' s) (gpa) og mikroskopiske polyangiitis (mpa).