Union européenne - néerlandais - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastische middelen - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Union européenne - néerlandais - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antineoplastische middelen - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Union européenne - néerlandais - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoom, niet-kleincellige long - antineoplastische middelen - tremelimumab astrazeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Pays-Bas - néerlandais - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

sandoz b.v. veluwezoom 22 1327 ah almere - midazolamhydrochloride samenstelling overeenkomend met ; ; midazolam 1 mg/ml - oplossing voor injectie of infusie - natriumchloride ; stikstof (head space) (e 941) ; water voor injectie ; zoutzuur (e 507), - midazolam

Pays-Bas - néerlandais - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

sandoz b.v. veluwezoom 22 1327 ah almere - midazolamhydrochloride samenstelling overeenkomend met ; ; midazolam 5 mg/ml - oplossing voor injectie of infusie - natriumchloride ; natriumhydroxide (e 524) ; stikstof (head space) (e 941) ; water voor injectie ; zoutzuur (e 507), - midazolam

Union européenne - néerlandais - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - neoplasmata van de borst - antineoplastische middelen - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Union européenne - néerlandais - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

Union européenne - néerlandais - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - precursorcel lymfoblastische leukemie-lymfoom - antineoplastische middelen - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Union européenne - néerlandais - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multiple myeloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combinatie met bortezomib, thalidomide en dexamethason voor de behandeling van volwassen patiënten met nieuw gediagnosticeerde multipel myeloom die in aanmerking komen voor een autologe stamceltransplantatie. in combinatie met lenalidomide en dexamethason, of bortezomib en dexamethason voor de behandeling van volwassen patiënten met multipel myeloom die minstens één eerdere therapie. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. als monotherapie voor de behandeling van volwassen patiënten met recidief en refractair multipel myeloom, van wie eerdere therapie opgenomen een proteasoom-remmer en een immunomodulerende agent en die blijk hebben gegeven van progressie van de ziekte op de laatste therapie. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Union européenne - néerlandais - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - multiple myeloma - antineoplastische middelen - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.