Sverige - svenska - Läkemedelsverket (Medical Products Agency)

koanaa healthcare gmbh - klofarabin - koncentrat till infusionsvätska, lösning - 1 mg/ml - klofarabin 1 mg aktiv substans

Europeiska unionen - svenska - 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.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

zentiva k.s. - busulfan - koncentrat till infusionsvätska, lösning - 6 mg/ml - busulfan 6 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

amring farma srl - melfalanhydroklorid - pulver och vätska till injektions-/infusionsvätska, lösning - 50 mg - melfalanhydroklorid 55,97 mg aktiv substans; etanol, vattenfri hjälpämne; propylenglykol hjälpämne

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

zentiva k.s. - talidomid - kapsel, hård - 50 mg - laktosmonohydrat hjälpämne; propylenglykol hjälpämne; talidomid 50 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

zentiva k.s. - imatinibmesilat - filmdragerad tablett - 100 mg - imatinibmesilat 119,5 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

zentiva k.s. - imatinibmesilat - filmdragerad tablett - 400 mg - imatinibmesilat 478 mg aktiv substans

Europeiska unionen - svenska - EMA (European Medicines Agency)

sandoz gmbh - pregabalin - anxiety disorders; epilepsy - antiepileptika, - epilepsypregabalin sandoz gmbh är indicerat som tilläggsbehandling för vuxna med partiella anfall med eller utan sekundär generalisering. generaliserad Ångest disorderpregabalin sandoz gmbh är indicerat för behandling av generaliserat ångestsyndrom (gad) hos vuxna.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

fairmed healthcare gmbh - karbidopa (monohydrat); levodopa - tablett - 25 mg/100 mg - levodopa 100 mg aktiv substans; karbidopa (monohydrat) 27 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

fairmed healthcare gmbh - karbidopa (monohydrat); levodopa - tablett - 12,5 mg/50 mg - karbidopa (monohydrat) 13,5 mg aktiv substans; levodopa 50 mg aktiv substans