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

medac gesellschaft für klinische spezialpräparate mbh - arsen trioxide - leukemi, promyelocytisk, akutt - antineoplastiske midler - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene. svarprosenten av andre akutt myelogen leukemi undertyper å arsen trioxide har ikke vært undersøkt.

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

accord healthcare s.l.u. - arsen trioxide - leukemi, promyelocytisk, akutt - antineoplastiske midler - arsen trioxide er indikert for induksjon av remisjon, og konsolidering hos voksne pasienter med nylig diagnostisert med lav til middels risiko for akutt promyelocytic leukemi (apl) (hvite blodlegemer, ≤ 10 x 103/µl) i kombinasjon med all-trans-retinsyre (atra)tilbakefall/ildfast akutt promyelocytic leukemi (apl)(tidligere behandling burde ha inneholdt en retinoid og kjemoterapi) er karakterisert ved tilstedeværelse av t(15;17) translocation og/eller tilstedeværelse av promyelocytic leukemi/retinoic acid-reseptor-alfa (pml/rar-alfa) - genet. svarprosenten av andre akutt myelogen leukemi undertyper å arsen trioxide har ikke vært undersøkt.

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

mylan ireland limited - arsen trioxide - leukemi, promyelocytisk, akutt - antineoplastiske midler - arsen trioxide mylan er indikert for induksjon av remisjon, og konsolidering hos voksne pasienter med nydiagnostisert lav til middels risiko for akutt promyelocytic leukemi (apl) (hvite blodlegemer, ≤ 10 x 103/µl) i kombinasjon med alle trans retinsyre (atra)- tilbakefall/ildfast akutt promyelocytic leukemi (apl) (tidligere behandling burde ha inneholdt en retinoid og kjemoterapi)er karakterisert ved tilstedeværelse av t(15;17) translocation og/eller tilstedeværelse av promyelocytic leukemi/retinsyre reseptor alfa (pml/rar alpha) - genet. svarprosenten av andre akutt myelogen leukemi undertyper å arsen trioxide har ikke beenexamined.

Norge - norsk - Statens legemiddelverk

mylan healthcare norge as - ispaghulafrøskall - pulver - 3.3 g/ dose

Norge - norsk - Statens legemiddelverk

viatris as - ispaghulafrøskall - granulat - 610 mg/ g

Norge - norsk - Statens legemiddelverk

viatris as - ispaghulafrøskall - granulat i dosepose - 610 mg/ g

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

sanofi winthrop industrie - teriflunomide - multippel sklerose - selektive immunosuppressiva - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

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

mylan ireland limited - fingolimod hydrochloride - multippel sklerose, relapsing-remitting - immunsuppressive - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 og 5. 1)orpatients med raskt utviklende alvorlig relapsing remitting multippel sklerose definert ved 2 eller flere deaktivere tilbakefall i ett år, og med 1 eller flere gadolinium å styrke lesjoner på brain mr eller en betydelig økning i t2 lesjon legg i forhold til en tidligere nyere mr.

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

mylan ireland limited - fingolimod hydrochloride - multippel sklerose, relapsing-remitting - immunsuppressive - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 og 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

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

mylan pharmaceuticals limited - teriflunomide - multippel sklerose, relapsing-remitting - immunsuppressive - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).