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

stemline therapeutics b.v. - selinexor - multipelt myelom - antineoplastiske midler - nexpovio is indicatedin combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

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

stemline therapeutics b.v. - tagraxofusp - lymphoma - antineoplastiske midler - elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (bpdcn).

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

stemline therapeutics b.v. - elacestrant - bryst neoplasmer - endokrine terapi - orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (er) positive, her2-negative, locally advanced or metastatic breast cancer with an activating esr1 mutation who have disease progression following at least one line of endocrine therapy including a cdk 4/6 inhibitor.

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)

amicus therapeutics europe limited - cipaglucosidase alfa - glycogen opbevaring sygdom type ii - andre alimentary tract and metabolism produkter, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).

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

ptc therapeutics international limited - eladocagene exuparvovec - aminosyre-metabolisme, infødte fejl - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.

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

orexigen therapeutics ireland limited - bupropion-hydrochlorid, naltrexon hydrochlorid - obesity; overweight - antiobesity preparations, excl. diætprodukter - mysimba er indiceret som et supplement til en reduceret kalorieindhold kost og øget fysisk aktivitet, for forvaltning af vægt hos voksne patienter (≥18 år) med en indledende body mass index (bmi)≥ 30 kg/m2 (fede), eller≥ 27 kg/m2 < 30 kg/m2 (overvægt) i tilstedeværelse af en eller flere vægt-relaterede co morbidities e. , type 2 diabetes, dyslipidaemia, eller kontrolleret hypertension)behandling med mysimba bør seponeres efter 16 uger, hvis patienterne ikke har tabt mindst 5% af deres oprindelige kropsvægt.

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

ptc therapeutics international limited - ataluren - muskeldystrofi, duchenne - andre midler mod forstyrrelser i muskel-skeletsystemet - translarna er indiceret til behandling af duchennes muskeldystrofi, der hidrører fra en nonsense mutation i dystrofin-genet, i ambulante patienter i alderen fra 2 år og ældre. effektivitet er ikke blevet demonstreret i ikke-ambulante patienter. tilstedeværelsen af en nonsense mutation i dystrofin-genet skal være bestemt af genetiske test.

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

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - andre narkotika stoffer - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

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

acorda therapeutics ireland limited - levodopa - parkinsons sygdom - anti-parkinson-lægemidler - inbrija er angivet for den intermitterende behandling af episodisk motoriske fluktuationer (off episoder) hos voksne patienter med parkinsons sygdom (pd) behandles med levodopa/dopa-decarboxylase inhibitor.