Den Europæiske Union - dansk - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - pemetrexed dinatriumhemipentahydrat - carcinoma, non-small-cell lung; mesothelioma - antineoplastiske midler - malignant pleural mesothelioma ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer ciambra 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. ciambra er angivet som monoterapi til vedligeholdelse behandling af lokalt avanceret eller metastatisk ikke-småcellet lungekræft andre end overvejende planocellulært histologi hos patienter, hvis sygdom ikke har udviklet sig som følger umiddelbart efter platin-baseret kemoterapi. ciambra er angivet som monoterapi for den anden linje behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft andre end overvejende planocellulært histologi.

Den Europæiske Union - dansk - 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 - antineoplastiske midler - 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. virkningen af glivec om resultatet af knogle-marrow transplantation er ikke fastlagt. 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. patienter, der har en lav eller meget lav risiko for tilbagefald, bør ikke modtage adjuverende behandling, behandling af voksne patienter med inoperabel dermatofibrosarcoma protuberans (dfsp) og voksne patienter med tilbagevendende og / eller metastatisk dfsp, som ikke er berettiget til kirurgi. i voksne og pædiatriske patienter, virkningen af glivec er baseret på det samlede hæmatologiske og cytogenetisk respons priser og progression-fri overlevelse i cml, på hæmatologiske og cytogenetisk respons priser i ph+ all, mds / mpd, på hæmatologiske svarprocenten i hes / cel og på objektive responsrater i voksne patienter med inoperabel og / eller metastatisk gist og dfsp og på recidiv-fri overlevelse i adjuvans kernen. erfaringerne med glivec hos patienter med mds / mpd, der er forbundet med pdgfr gen re-arrangementer er meget begrænset (se afsnit 5. undtagen i nyligt diagnosticeret kronisk cml-fase, der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord 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-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. undtagen i nyligt diagnosticeret kronisk cml-fase, der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme. .

Den Europæiske Union - dansk - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. virkning af imatinib om resultatet af bone marrow transplantation er ikke fastlagt. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. erfaringerne med imatinib i patienter med mds/mpd, der er forbundet med pdgfr gen re-arrangementer er meget begrænset. der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

zoetis belgium sa - maropitant citrat - alimentary tract and metabolism - dogs; cats - tabletter hunde: til forebyggelse af kvalme induceret ved kemoterapi. til forebyggelse af opkast induceret af motion sygdom. til forebyggelse og behandling af opkastning i forbindelse med cerenia injektionsvæske, opløsning og i kombination med andre understøttende foranstaltninger. løsning til injectiondogs:til behandling og forebyggelse af kvalme, der er fremkaldt af kemoterapi. til forebyggelse af opkastning bortset fra det, der induceres af motionssygdom. til behandling af opkastning, i kombination med andre understøttende foranstaltninger. til forebyggelse af perioperative kvalme og opkastning og forbedring i nyttiggørelse af generel anæstesi efter brug af μ-opioid receptor agonist morfin. katte: til forebyggelse af opkastning og reduktion af kvalme, bortset fra det, der fremkaldes af bevægelsessyge. til behandling af opkastning, i kombination med andre understøttende foranstaltninger.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermin - mucositis - alle andre terapeutiske produkter - kepivance er angivet til at reducere hyppigheden, varigheden og sværhedsgraden af oral mucositis hos voksne patienter med maligne hæmatologiske sygdomme modtager myeloablative radiochemotherapy forbundet med en høj forekomst af svær mucositis og kræver autolog-hæmatopoietisk-stamcelle-support.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

teva b.v. - lipegfilgrastim - neutropeni - immunostimulants, , koloni-stimulerende faktorer - lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

roche registration gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell - antineoplastiske midler - mabthera er angivet i voksne til følgende indikationer:non‑hodgkin ' s lymfom (nhl)mabthera er indiceret til behandling af tidligere ubehandlede voksne patienter med stadium iii‑iv, follikulært lymfom i kombination med kemoterapi. mabthera vedligeholdelse terapi er indiceret til behandling af voksne follikulært lymfom patienter reagerer på induktion terapi. mabthera monoterapi er indiceret til behandling af voksne patienter med stadium iii‑iv, follikulært lymfom, der er chemoresistant eller er i deres andet eller efterfølgende tilbagefald efter kemoterapi. mabthera er indiceret til behandling af voksne patienter med cd20-positive diffuse store b-celle non‑hodgkin ' s lymfom i kombination med chop (cyclofosfamid, doxorubicin, vincristin, prednisolon) kemoterapi. mabthera i kombination med kemoterapi er indiceret til behandling af pædiatriske patienter (i alderen ≥ 6 måneder < 18 år) med tidligere ubehandlet fremskredent stadium cd20-positive diffuse store b-celle lymfom (dlbcl), burkitt lymfom (bl)/burkitt leukæmi (mature b-celle akut leukæmi) (bal) eller burkitt-som lymfom (bll). kronisk lymfatisk leukæmi (cll)mabthera i kombination med kemoterapi er indiceret til behandling af patienter med tidligere ubehandlet og recidiverende/refraktær cll. foreligger kun begrænsede oplysninger om effekt og sikkerhed for patienter, der tidligere er behandlet med monoklonale antistoffer, herunder mabthera eller patienter ildfaste materialer til tidligere mabthera plus kemoterapi. reumatoid arthritismabthera i kombination med methotrexat er indiceret til behandling af voksne patienter med svær aktiv leddegigt, der har haft et utilstrækkeligt respons eller intolerance over for andre sygdomsmodificerende anti‑reumatiske lægemidler (dmard), herunder en eller flere tumor nekrose faktor (tnf) - hæmmer behandlinger. mabthera har vist sig at reducere hastigheden af progressionen af ledskader, som målt ved hjælp af x‑ray, og til at forbedre den fysiske funktion, når det gives i kombination med methotrexat. granulomatosis med polyangiitis og mikroskopiske polyangiitismabthera, i kombination med glukokortikoider er indiceret til behandling af voksne patienter med svær, aktive granulomatosis med polyangiitis (wegeners) (gpa) og mikroskopisk polyangiitis (mpa). mabthera i kombination med glukokortikoider er indiceret til induktion af remission hos pædiatriske patienter (i alderen ≥ 2 < 18 år) med svær, aktive gpa (wegeners) og mpa. pemphigus vulgarismabthera er indiceret til behandling af patienter med moderat til svær pemphigus vulgaris (pv).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - leukæmi, lymfocytisk, kronisk, b-celle - antineoplastiske midler - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - thalidomid - multipelt myelom - immunosuppressiva - 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.