Európska únia - dánčina - EMA (European Medicines Agency)

extrovis eu ltd. - lacosamid - epilepsi - antiepileptika, - lacosamide adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. lacosamide adroiq is indicated as adjunctive therapyin the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Európska únia - dánčina - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastiske midler - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Európska únia - dánčina - EMA (European Medicines Agency)

ceva-phylaxia co. ltd. - celleassocieret levende rekombinant kalkunherpesvirus (rhvt / nd), der udtrykker fusionsproteinet af newcastle disease-virus-d-26-lentogen stamme - immunologicals for aves, live viral vacciner - chicken; embryonated eggs - til aktiv immunisering af 18 dage gamle befrugtede æg eller en-dage gamle kyllinger til at reducere dødelighed og kliniske tegn forårsaget af newcastle disease virus og til at reducere dødeligheden, kliniske tegn og læsioner forårsaget af marek ' s disease virus med en fænotype, der er "fremme i skoene".

Európska únia - dánčina - EMA (European Medicines Agency)

ceva santé animale - inaktiverede influenza-a-virus / svin - immunologiske - svin - aktiv immunisering af svin fra 56-års alderen, herunder gravide søer mod svineinfluenza forårsaget af subtype h1n1, h3n2 og h1n2 for at reducere kliniske tegn og viral lungelast efter infektion.. starten af immunitet: 7 dage efter den primære vaccinationduration af immunitet: 4 måneder i svin vaccineret mellem alder af 56 år, og 96 dage og 6 måneder i svin vaccineret for første gang ved 96 dage, og over. aktiv immunisering af gravide søer efter færdig primær immunisering ved indgift af en enkeltdosis 14 dage før farvning for at udvikle høj colostral immunitet, som giver klinisk beskyttelse af smågrise i mindst 33 dage efter fødslen.

Európska únia - dánčina - EMA (European Medicines Agency)

accord healthcare s.l.u. - cabazitaxel - prostatic neoplasmer, kastration-resistent - antineoplastiske midler - treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Európska únia - dánčina - 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.

Európska únia - dánčina - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastiske midler - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Európska únia - dánčina - EMA (European Medicines Agency)

eli lilly nederland b.v. - glucagon - diabetes mellitus - pancreas hormoner, hormoner glycogenolytic - baqsimi er indiceret til behandling af alvorlig hypoglykæmi hos voksne, unge og børn i alderen 4 år og derover med diabetes mellitus.

Európska únia - dánčina - EMA (European Medicines Agency)

mylan s.a.s - ambrisentan - hypertension, lunge - antihypertensiva, - ambrisentan mylan er indiceret til behandling af pulmonal arteriel hypertension (pah) hos voksne patienter, som funktionel class (fc) ii til iii, herunder til brug i kombination behandling. effektivitet er blevet vist i idiopatisk pah (ipah) og i pah associeret med bindevævssygdom. ambrisentan mylan er indiceret til behandling af pulmonal arteriel hypertension (pah) hos voksne patienter, som funktionel class (fc) ii til iii, herunder til brug i kombination behandling. effektivitet er blevet vist i idiopatisk pah (ipah) og i pah associeret med bindevævssygdom.

Európska únia - dánčina - EMA (European Medicines Agency)

sanofi pasteur - neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid - meningitis, meningokok - vacciner - menquadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y. the use of this vaccine should be in accordance with available official recommendations.