Euroopan unioni - suomi - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinibi - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinibi - 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. paitsi äskettäin diagnosoitu kroonisen vaiheen kml, ei ole kontrolloituja tutkimuksia, jotka osoittaisivat kliinistä tehoa tai eloonjäämisetua näissä sairauksia. .

Suomi - suomi - Fimea (Suomen lääkevirasto)

gebro pharma gmbh - sugammadex sodium - injektioneste, liuos - 100 mg/ml - sugammadeksi

Suomi - suomi - Fimea (Suomen lääkevirasto)

gambro lundia ab - natrii lactas anhydricus,magnesiumia chloridum hexahydricum,kalsiumia chloridum dihydricum,natrii chloridum,glukoosi anhydricum - peritoneaalidialyysineste - 15 mg/ml - isotoniset liuokset

Suomi - suomi - Fimea (Suomen lääkevirasto)

gambro lundia ab - glucosum anhydricum,magnesii chloridum hexahydricum,natrii lactas anhydricus,natrii chloridum,calcii chloridum dihydricum - peritoneaalidialyysineste - 40 mg/ml - hypertoniset liuokset

Suomi - suomi - Fimea (Suomen lääkevirasto)

gambro lundia ab - natrii lactas anhydricus,magnesii chloridum hexahydricum,natrii chloridum,glucosum anhydricum,calcii chloridum dihydricum - peritoneaalidialyysineste - 25 mg/ml - hypertoniset liuokset

Suomi - suomi - Fimea (Suomen lääkevirasto)

gambro lundia ab - calcii chloridum dihydricum,glucosum anhydricum,magnesii chloridum hexahydricum,natrii chloridum,natrii lactas anhydricus - peritoneaalidialyysineste - 15 mg/ml - isotoniset liuokset

Suomi - suomi - Fimea (Suomen lääkevirasto)

gambro lundia ab - magnesium chloridum hexahydricum,kalsiumia chloridum dihydricum,natrii lactas anhydricus,glukoosi anhydricum,natrii chloridum - peritoneaalidialyysineste - 25 mg/ml - hypertoniset liuokset

Suomi - suomi - Fimea (Suomen lääkevirasto)

gambro lundia ab - magnesii chloridum hexahydricum,calcii chloridum dihydricum,glucosum anhydricum,natrii lactas anhydricus,glucosum monohydricum,natrii chloridum - peritoneaalidialyysineste - 40 mg/ml - hypertoniset liuokset

Suomi - suomi - Fimea (Suomen lääkevirasto)

gambro lundia ab - natrii lactas anhydricus,magnesii chloridum hexahydricum,glucosum anhydricum,calcii chloridum dihydricum,natrii chloridum - peritoneaalidialyysineste - 25 mg/ml - hypertoniset liuokset

Suomi - suomi - Fimea (Suomen lääkevirasto)

gambro lundia ab - natrii chloridum,glukoosi anhydricum,kalsiumia chloridum dihydricum,natrii lactas anhydricus,magnesiumia chloridum hexahydricum - peritoneaalidialyysineste - 40 mg/ml - hypertoniset liuokset