Європейський Союз - данська - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinale stromale tumorer - andre antineoplastiske midler, protein kinase hæmmere - 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.

Європейський Союз - данська - EMA (European Medicines Agency)

merck sharp and dohme b.v - ribavirin - hepatitis c kronisk - antivirals for systemic use, antivirals for treatment of hcv infections - rebetol er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis c (chc) hos voksne. rebetol er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis c (chc) for pædiatriske patienter (børn fra 3 år og ældre og unge), der ikke tidligere er behandlet, og uden leveren dekompensation.

Європейський Союз - данська - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - treosulfan - hematopoietisk stamcelletransplantation - antineoplastiske midler - treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.

Європейський Союз - данська - EMA (European Medicines Agency)

laboratorios lesvi s.l. - dimethylfumarat - multipel sklerose, recidiverende-remitterende - immunosuppressiva - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Європейський Союз - данська - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - bryst neoplasmer - antineoplastiske midler - 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.

Європейський Союз - данська - EMA (European Medicines Agency)

novartis europharm limited - nilotinib - leukæmi, myelogen, kronisk, bcr-abl positiv - antineoplastiske midler - tasigna er indiceret til behandling af:voksne og pædiatriske patienter med nyligt diagnosticeret philadelphia-kromosom-positiv kronisk myelogenous leukæmi (cml) i den kroniske fase,pædiatriske patienter med philadelphia-kromosom-positiv cml i kronisk fase med resistens eller intolerans til forudgående behandling, herunder imatinib. tasigna er indiceret til behandling af:voksne og pædiatriske patienter med nyligt diagnosticeret philadelphia-kromosom-positiv kronisk myelogenous leukæmi (cml) i den kroniske fase,voksne patienter med kronisk fase og accelereret fase philadelphia-kromosom-positiv cml med resistens eller intolerans til forudgående behandling, herunder imatinib. effektivitetsdata hos patienter med cml i blast krise er ikke tilgængelige,pædiatriske patienter med kroniske fase philadelphia-kromosom-positiv cml med resistens eller intolerans til forudgående behandling, herunder imatinib.

Данія - данська - Lægemiddelstyrelsen (Danish Medicines Agency)

actavis group ptc ehf. - irinotecanhydrochloridtrihydrat - koncentrat til infusionsvæske, opløsning - 20 mg/ml

Данія - данська - Lægemiddelstyrelsen (Danish Medicines Agency)

fresenius kabi ab - irinotecanhydrochloridtrihydrat - koncentrat til infusionsvæske, opløsning - 20 mg/ml

Європейський Союз - данська - EMA (European Medicines Agency)

janssen-cilag international nv - simeprevir - hepatitis c kronisk - antivirale midler til systemisk anvendelse - olysio er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis c (chc) hos voksne patienter. for at hepatitis c virus (hcv) genotype specifikke aktivitet.

Данія - данська - Lægemiddelstyrelsen (Danish Medicines Agency)

fresenius kabi ab - irinotecanhydrochloridtrihydrat - koncentrat til infusionsvæske, opløsning - 20 mg/ml