欧州連合 - ノルウェー語 - EMA (European Medicines Agency)

takeda pharma a/s - ferumoxytol - anemia; kidney failure, chronic - andre antianemic preparations - rienso er indisert for intravenøs behandling av jernmangelanemi hos voksne pasienter med kronisk nyresykdom (ckd). diagnostikk av jernmangel må være basert på aktuelle laboratorieprøver (se kapittel 4.

ノルウェー - ノルウェー語 - Statens legemiddelverk

baxter medical ab - retinylpalmitat / kolekalsiferol / tokoferol alfa / askorbinsyre / tiamin / riboflavinnatriumfosfathydrat / pyridoksinhydroklorid / cyanokobalamin / folsyre / pantotensyre / biotin / nikotinamid - pulver til injeksjons-/infusjonsvæske, oppløsning - 3500 ie / 220 ie / 11.2 ie / 125 mg / 3.51 mg / 4.14 mg / 4.53 mg / 0.006 mg / 0.414 mg / 17.25 mg / 0.069 mg / 46 mg

欧州連合 - ノルウェー語 - EMA (European Medicines Agency)

viiv healthcare bv - lamivudine, zidovudine - hiv-infeksjoner - antivirale midler til systemisk bruk - combivir is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection.

欧州連合 - ノルウェー語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - 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. bortsett fra i nydiagnostisert kronisk fase kml, det er ingen kontrollerte studier som viser en klinisk nytte eller økt overlevelse for disse sykdommer. .

欧州連合 - ノルウェー語 - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. effekten av imatinib på utfallet av bein marg transplantasjon har ikke fastsatt. imatinib actavis is indicated for: , 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. erfaring med imatinib hos pasienter med mds/mpd forbundet med pdgfr gene re-ordninger er svært begrenset. det er ingen kontrollerte studier som viser en klinisk nytte eller økt overlevelse for disse sykdommer.

欧州連合 - ノルウェー語 - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva er angitt for behandling ofadult og paediatric pasienter med nylig diagnostisert philadelphia-kromosom (bcr‑abl) positiv (ph+) kronisk myelogen leukemi (cml) for hvem bein marg transplantasjon er ikke ansett som den første linje behandling av. voksne og paediatric pasienter med ph+ kml i kronisk fase etter svikt av interferon‑alfa terapi, eller i akselerert fase eller sprenge krise. voksne og paediatric pasienter med nylig diagnostisert philadelphia kromosom positive akutt lymfoblastisk leukemi (ph+ all) integrert med kjemoterapi. voksne pasienter med tilbakefall eller ildfast ph+ alle som monoterapi. voksne pasienter med myelodysplastic/myeloproliferativ sykdom (mds/mpd) er forbundet med blodplate-avledet vekstfaktor reseptor (pdgfr) gene re-ordninger. voksne pasienter med avansert hypereosinophilic syndrom (hms) og/eller kronisk eosinofil leukemi (cel) med fip1l1-pdgfra omorganisering. effekten av imatinib på utfallet av bein marg transplantasjon har ikke fastsatt. imatinib teva 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.

欧州連合 - ノルウェー語 - EMA (European Medicines Agency)

intervet international bv - equine influenza-virus stammer: a / equine-2 / sør-afrika / 4/03, a / equine-2 / newmarket / 2/93 - equine influenza virus - hester - aktiv immunisering av hester fra seks måneder mot hesteinfluensa for å redusere kliniske tegn og virusutskillelse etter infeksjon.

欧州連合 - ノルウェー語 - EMA (European Medicines Agency)

intervet international bv - equine influenza-virus stammer: a / equine-2 / sør-afrika / 4/03, a / equine-2 / newmarket / 2/93, tetanus toxoid - equine influenza virus + clostridium - hester - aktiv vaksinering av hester fra seks måneders alder mot equine influenza for å redusere kliniske tegn og virus utskillelse etter infeksjon og aktiv vaksinasjon mot stivkrampe å forhindre dødelighet.

欧州連合 - ノルウェー語 - EMA (European Medicines Agency)

intervet international bv - tetanustoksoid - immunologier for hovdyr - hester - aktiv immunisering av hester fra 6 måneder mot tetanus for å forhindre dødelighet. utbruddet av immunitet: 2 uker etter den primære vaksinasjon courseduration av immunitet: 17 måneder etter at den primære vaksinasjon kurs, 24 måneder etter den første revaccination.

欧州連合 - ノルウェー語 - EMA (European Medicines Agency)

intervet international bv - leptospira interrogans serogruppe canicola serovar portland-vere (belastning ca-12-000), l. interrogans serogruppe icterohaemorrhagiae serovar copenhageni (belastning ic-02-001), l. interrogans serogruppe australis serovar bratislava (belastning som-05-073), l. kirschneri serogruppe grippotyphosa serovar dadas (belastning gr-01-005) - immunologicals - hunder - for aktive vaksinasjon av dyr mot:leptospira interrogans serogruppe canicola serovar canicola for å redusere smitte og urinutskillelse;l. interrogans serogruppe icterohaemorrhagiae serovar copenhageni for å redusere smitte og urinutskillelse;l. interrogans serogruppe australis serovar bratislava for å redusere smitte;l. kirschneri serogruppe grippotyphosa serovar bananal / lianguang for å redusere infeksjon og urinutskillelse.