Euroopan unioni - suomi - 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 - antineoplastiset aineet - 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. potilaat, joilla on alhainen tai hyvin alhainen riski toistumisen pitäisi saada adjuvanttihoitona. 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. paitsi äskettäin diagnosoitu kroonisen vaiheen kml, ei ole kontrolloituja tutkimuksia, jotka osoittaisivat kliinistä tehoa tai eloonjäämisetua näissä sairauksia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leukemia, myelogeeninen, krooninen, bcr-abl positiivinen - antineoplastiset aineet - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - glargininsuliini - diabetes mellitus - diabeetilla käytettävät lääkkeet - diabetes mellituksen hoito aikuisilla, nuorilla ja kahdella tai useammalla lapsella.

Suomi - suomi - Fimea (Suomen lääkevirasto)

hospira uk ltd. - octreotidi acetas - injektioneste, liuos - 50 mikrog/ml - oktreotidi

Suomi - suomi - Fimea (Suomen lääkevirasto)

hospira uk ltd. - octreotidi acetas - injektioneste, liuos - 100 mikrog/ml - oktreotidi

Suomi - suomi - Fimea (Suomen lääkevirasto)

hospira uk ltd. - octreotidi acetas - injektioneste, liuos - 200 mikrog/ml - oktreotidi

Suomi - suomi - Fimea (Suomen lääkevirasto)

hospira uk ltd. - octreotidi acetas - injektioneste, liuos - 500 mikrog/ml - oktreotidi

Euroopan unioni - suomi - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - glargininsuliini - diabetes mellitus - diabeetilla käytettävät lääkkeet - diabetes mellituksen hoitoon aikuisille, nuorille ja lapsille 6-vuotiaille.

Suomi - suomi - Fimea (Suomen lääkevirasto)

primex pharmaceuticals oy - dobutamini hydrochloridum - infuusiokonsentraatti, liuosta varten - 50 mg/ml - dobutamiini

Suomi - suomi - Fimea (Suomen lääkevirasto)

chanelle pharmaceuticals manufacturing limited - febantel, praziquantel, pyrantel embonate - tabletti - 50 mg / 144 mg / 150 mg - pratsikvanteeli