Den europeiske union - norsk - 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 - antineoplastiske midler - 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. pasienter som har en lav eller svært lav risiko for tilbakefall bør ikke får 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. bortsett fra i nydiagnostisert kronisk fase kml, det er ingen kontrollerte studier som viser en klinisk nytte eller økt overlevelse for disse sykdommer.

Norge - norsk - Statens legemiddelverk

fair-med healthcare gmbh - karbidopamonohydrat / levodopa - tablett - 12.5 mg / 50 mg

Norge - norsk - Statens legemiddelverk

fair-med healthcare gmbh - karbidopamonohydrat / levodopa - tablett - 25 mg / 100 mg

Den europeiske union - norsk - EMA (European Medicines Agency)

viatris healthcare limited - tobramycin - cystic fibrosis; respiratory tract infections - antibakterielle midler for systemisk bruk, - tobi podhaler er angitt for undertrykkende behandling av kroniske lunge infeksjoner forårsaket av pseudomonas aeruginosa i voksne og barn i alderen 6 år og eldre med cystisk fibrose. se avsnitt 4. 4 og 5. 1 om data i ulike aldersgrupper. det bør vurderes å offisielle retningslinjer for riktig bruk av antibakterielle midler.

Norge - norsk - Statens legemiddelverk

accord healthcare b.v. - epirubicinhydroklorid - injeksjons-/infusjonsvæske, oppløsning - 2 mg/ ml

Den europeiske union - norsk - EMA (European Medicines Agency)

elanco gmbh - robenacoxib - anti-inflammatory and anti-rheumatic products, non-steroids, coxibs - dogs; cats - katter (tabletter):for treatmentrelief av smerter og betennelser assosiert med akutt andor kroniske muskel-og skjelettlidelser. for reduksjon av moderate smerter og betennelser assosiert med ortopedisk kirurgi. hunder (tabletter):for ttreatment av smerter og betennelser assosiert med kronisk osteoartritt. for behandling av smerter og betennelser assosiert med myke vev kirurgi. katter og hunder (løsning for injeksjon):for ttreatment av smerter og betennelser assosiert med ortopediske eller bløtvev kirurgi.

Norge - norsk - Statens legemiddelverk

orifarm healthcare a/s - fenazon / koffein - tablett - 500 mg / 100 mg

Norge - norsk - Statens legemiddelverk

orifarm healthcare a/s - fenazon / koffein - tablett - 1 g / 100 mg

Norge - norsk - Statens legemiddelverk

clinigen healthcare b.v. - glykopyrroniumbromid - mikstur, oppløsning med jordbærsmak - 160 mikrog/ ml

Norge - norsk - Statens legemiddelverk

orifarm healthcare a/s - jern(ii)sulfat, tørret - depottablett - 100 mg