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

ab science s.a. - masitinib mesilate - antineoplastiske midler - hunde - behandling af ikke-resekterbare hunmastcelletumorer (grad 2 eller 3) med bekræftet muteret c-kit tyrosin-kinase receptor.

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

ab science - masitinib mesilate - mastocytose - antineoplastiske midler - behandling af mastocytose.

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

ab science - masitinib - bukspyttkjertel-neoplasmer - protein kinase hæmmere - behandling af ikke resectable lokalt fremskreden eller metastatisk kræft i bugspytkirtlen.

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

masitinib - gastrointestinale stromale tumorer - protein kinase hæmmere - behandling af inoperabel og/eller metastatisk maligne gastrointestinale stromale tumor (gist).

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

ab science - masitinib mesilate - amyotrofisk lateral sklerose - antineoplastiske midler - behandling af amyotrofisk lateral sklerose.

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)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiske midler - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

sandoz a/s - imatinibmesilat - filmovertrukne tabletter - 100 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

mylan ab - imatinibmesilat - filmovertrukne tabletter - 100 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

stada arzneimittel ag - imatinibmesilat - filmovertrukne tabletter - 600 mg