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

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastiske midler - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

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

boehringer ingelheim international gmbh - nintedanib - karsinom, ikke-småcellet lunge - antineoplastiske midler - vargatef angis i kombinasjon med docetaxel for behandling av voksne pasienter med lokalt avansert, metastatisk eller lokalt tilbakevendende ikke-småcellet lungekreft (nsclc) for adenocarcinoma svulst histology etter første linje kjemoterapi.

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

astrazeneca ab - osimertinib mesilate - karsinom, ikke-småcellet lunge - andre cytostatika, protein kinase hemmere - 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.

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

janssen-cilag international nv - bortezomib - multippelt myelom - antineoplastiske midler - velcade som monoterapi eller i kombinasjon med pegylert liposomal doksorubicin eller deksametason er indisert for behandling av voksne pasienter med progressiv myelom som har mottatt minst 1 før terapi og som allerede har gjennomgått eller uegnet for haematopoietic stamcelletransplantasjon. velcade i kombinasjon med melphalan og prednison er indisert for behandling av voksne pasienter med tidligere ubehandlet myelomatose som ikke er kvalifisert for høy dose kjemoterapi med haematopoietic stilk cellen transplantasjon. velcade i kombinasjon med deksametason, eller med dexamethasone og thalidomid, er indikert for induksjon behandling av voksne pasienter med tidligere ubehandlet myelomatose som er kvalifisert for høy dose kjemoterapi med haematopoietic stilk cellen transplantasjon. velcade i kombinasjon med rituximab, cyklofosfamid, doxorubicin og prednison er indisert for behandling av voksne pasienter med tidligere ubehandlet mantelen celle lymfom som er uegnet for haematopoietic stilk cellen transplantasjon.

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

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiske midler - sprycel er angitt for behandling av paediatric pasienter med nylig diagnostisert philadelphia kromosom-positiv kronisk myelogen leukemi i kronisk fase (ph+ cml cp) eller ph+ cml cp resistente eller intolerante til før terapi inkludert imatinib. nylig diagnostisert ph+ akutt lymfoblastisk leukemi (all) i kombinasjon med kjemoterapi. sprycel er indisert for behandling av voksne pasienter med nydiagnostisert philadelphia-kromosom-positive (ph+) kronisk myelogen leukemi (cml) i den kroniske fasen;kronisk, akselerert eller sprenge fase kml med resistens eller intoleranse overfor tidligere behandling inkludert imatinib mesilate;ph+ akutt lymfoblastisk leukemi (all) og lymfoide blast cml med resistens eller intoleranse overfor tidligere behandling. sprycel er angitt for behandling av paediatric pasienter med nylig diagnostisert ph+ kml i kronisk fase (ph+ cml-cp) eller ph+ cml-cp resistente eller intolerante til før terapi inkludert imatinib.

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

bristol-myers squibb pharma eeig - thalidomid - multippelt myelom - immunsuppressive - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

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

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastiske midler - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

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

advanced accelerator applications - edotreotide - neuroendocrine tumors; radionuclide imaging - diagnostiske radiopharmaceuticals - dette legemidlet er kun til diagnostisk bruk. etter radiolabelling med gallium (68ga) klorid løsning, løsning av gallium (68ga) edotreotide fått er indikert for positron emisjon tomografi (pet) avbildningen av somatostatin reseptor overexpression hos voksne pasienter med bekreftet eller mistenkt godt differensiert gastro-enteropancreatic nevroendokrine svulster (gep-net) for lokalisering av primære svulster og deres metastaser.

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

roche registration gmbh - alectinibhydroklorid - karsinom, ikke-småcellet lunge - antineoplastiske midler - alecensa som monoterapi er indisert for førstegangsbehandling av voksne pasienter med anaplastisk lymfomkinase (alk) -positive avansert ikke-småcellet lungekreft (nsclc). alecensa som monoterapi er indisert for behandling av voksne pasienter med alk‑positive avansert nsclc som tidligere er behandlet med crizotinib.

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

accord healthcare s.l.u. - pemetrexed dinatriumhemipentahydrat - carcinoma, non-small-cell lung; mesothelioma - antineoplastiske midler - ondartet pleural mesotheliomapemetrexed avtalen i kombinasjon med cisplatin er angitt for behandling av kjemoterapi naive pasienter med inoperabel ondartet pleural mesothelioma. non-small cell lung cancerpemetrexed avtalen i kombinasjon med cisplatin er angitt for den første linje behandling av pasienter med lokalt avansert eller metastatisk ikke-liten celle lunge kreft annet enn overveiende plateepitelkreft histology. pemetrexed accord er indisert som monoterapi for vedlikehold behandling av lokalt avansert eller metastatisk ikke-liten celle lunge kreft annet enn overveiende plateepitelkreft histology hos pasienter med sykdommen har ikke kommet umiddelbart etter platinum-basert kjemoterapi. pemetrexed accord er indisert som monoterapi for den andre linjen behandling av pasienter med lokalt avansert eller metastatisk ikke-liten celle lunge kreft annet enn overveiende plateepitelkreft histology.