Ευρωπαϊκή Ένωση - Σουηδικά - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastiska medel - imatinib koanaa is indicated for the treatment ofadult 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. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe 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 som har en låg eller mycket låg risk för återfall bör inte få adjuvant behandling. 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. 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 gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. förutom vid nyligen diagnostiserad kml kronisk fas, det finns inga kontrollerade studier som visar på en klinisk nytta eller ökad överlevnad för dessa sjukdomar.

Σουηδία - Σουηδικά - Läkemedelsverket (Medical Products Agency)

2care4 aps - takrolimusmonohydrat - salva - 0,1% - takrolimusmonohydrat 1,02 mg aktiv substans

Σουηδία - Σουηδικά - Läkemedelsverket (Medical Products Agency)

paranova läkemedel ab - takrolimusmonohydrat - salva - 1 mg/g - takrolimusmonohydrat 1,02 mg aktiv substans

Σουηδία - Σουηδικά - Läkemedelsverket (Medical Products Agency)

ebb medical ab - takrolimusmonohydrat - salva - 1 mg/g - takrolimusmonohydrat 1,02 mg aktiv substans

Σουηδία - Σουηδικά - Läkemedelsverket (Medical Products Agency)

accord healthcare b.v. - takrolimusmonohydrat - salva - 0,03% - takrolimusmonohydrat 0,306 mg aktiv substans

Σουηδία - Σουηδικά - Läkemedelsverket (Medical Products Agency)

abacus medicine a/s - takrolimusmonohydrat - salva - 1 mg/g - takrolimusmonohydrat 1,02 mg aktiv substans