Den Europæiske Union - dansk - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pharming group n.v. - rekombinant human c1-inhibitor - angioødemer, arvelige - drugs used in hereditary angioedema, other hematological agents - ruconest er indiceret til behandling af akut angioødemangreb hos voksne med arveligt angioødem (hae) på grund af c1-esterase-hæmmere mangel.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

nanotherapeutics bohumil, s.r.o. - whole virion influenza vaccine, inactivated containing antigen of strain a/california/07/2009 (h1n1)v - disease outbreaks; influenza, human; immunization - vacciner - profylakse af influenza forårsaget af a (h1n1) v 2009 virus. celvapan bør anvendes i overensstemmelse med officielle retningslinjer.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

alfasigma s.p.a. - methylthioniniumchlorid - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

Den Europæiske Union - dansk - 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. virkning af imatinib om resultatet af bone marrow transplantation er ikke fastlagt. 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. erfaringerne med imatinib i patienter med mds/mpd, der er forbundet med pdgfr gen re-arrangementer er meget begrænset. der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumine - ef-erhvervede infektioner - antibakterielle midler til systemisk brug, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 og 5. det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan ireland limited - abiraterone acetat - prostatiske neoplasmer - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

nanotherapeutics bohumil s.r.o. - influenzavirus a/california/7/2009 (h1n1)v-lign. stamme, inaktiverede split virioner, influenzavirus a/perth/16/2009 (h3n2) lignende stamme (a/victoria/210/2009 nymc x-187 reassortant), influenzavirus b/brisbane/60/2008, split virioner, inaktiveret - injektionsvæske, suspension, fyldt injektionssprøjte - 15 mikrogram

Den Europæiske Union - dansk - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioødemer, arvelige - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioødemer, arvelige - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.