Unió Europea - islandès - 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 - Æxlishemjandi lyf - 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. sjúklingar sem hafa lítil eða mjög lítil hætta á endurkomu ætti ekki að fá viðbótar meðferð. 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. nema í nýlega greind langvarandi áfanga cml, það eru ekki stjórnað rannsóknir sýna klínískum gagnast eða jókst að lifa fyrir þessum sjúkdómum.

Islàndia - islandès - LYFJASTOFNUN (Icelandic Medicines Agency)

medac gesellschaft für klinische spezialpräparate gmbh - mitomycinum inn - duft og leysir fyrir þvagblöðrulausn - 40 mg

Islàndia - islandès - LYFJASTOFNUN (Icelandic Medicines Agency)

csl behring gmbh* - human fibrinogen - stungulyfs-/innrennslisstofn, lausn - 1 g

Unió Europea - islandès - EMA (European Medicines Agency)

dany bienenwohl gmbh - oxalsýru tvíhýdrat - ectoparasiticides fyrir baugi nota, meðtalin. skordýraeitur - býflugur - fyrir meðferð varroosis (varroa anti -) af býflugur hunang (api mellifera) í ungum-frjáls nýlendur.

Unió Europea - islandès - EMA (European Medicines Agency)

dany bienenwohl gmbh - oxalsýru tvíhýdrat - ectoparasiticides for topical use, incl. insecticides, ectoparaciticides, insecticides and repellents - honey bees - fyrir meðferð varroosis (varroa anti -) af býflugur hunang (api mellifera) í ungum-frjáls nýlendur.

Unió Europea - islandès - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - sapropterin díhýdróklóríð - phenylketonurias - Önnur meltingarvegi og efnaskipti vörur, - sapropterin dipharma is indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with phenylketonuria (pku) who have been shown to be responsive to such treatment. sapropterin dipharma is also indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with tetrahydrobiopterin (bh4) deficiency who have been shown to be responsive to such treatment.

Islàndia - islandès - LYFJASTOFNUN (Icelandic Medicines Agency)

fresenius medical care deutschland gmbh - natrii chloridum; calcii chloridum; magnesii chloridum; glucosum; natrii lactas - kviðskilunarlausn - 1,5 %

Islàndia - islandès - LYFJASTOFNUN (Icelandic Medicines Agency)

fresenius medical care deutschland gmbh - natrii chloridum; calcii chloridum; magnesii chloridum; glucosum; natrii lactas - kviðskilunarlausn - 2,3 %

Islàndia - islandès - LYFJASTOFNUN (Icelandic Medicines Agency)

fresenius medical care deutschland gmbh - natrii chloridum; calcii chloridum; magnesii chloridum; glucosum; natrii lactas - kviðskilunarlausn - 4,25 %

Islàndia - islandès - LYFJASTOFNUN (Icelandic Medicines Agency)

baxalta innovations gmbh - human serum albumin - innrennslislyf, lausn - 200 g/l