Uniunea Europeană - daneză - EMA (European Medicines Agency)

santen oy - netarsudil - glaucoma, open-angle; ocular hypertension - oftalmologiske - reduktion af forhøjet intraokulært tryk (iop) hos voksne patienter med primær åbenvinklet glaukom eller okulær hypertension.

Danemarca - daneză - Lægemiddelstyrelsen (Danish Medicines Agency)

aristo pharma gmbh - natriumoxybat - oral opløsning - 500 mg/ml

Uniunea Europeană - daneză - EMA (European Medicines Agency)

santen oy - latanoprost, netarsudil mesilate - glaucoma, open-angle; ocular hypertension - oftalmologiske - roclanda is indicated for the reduction of elevated intraocular pressure (iop) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient iop reduction.

Uniunea Europeană - daneză - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - andre antiepileptika - ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 to 17 years of age. ztalmy may be continued in patients 18 years of age and older.

Uniunea Europeană - daneză - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - immunosuppressiva - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. psoriasis arthritiscosentyx, alene eller i kombination med methotrexat (mtx), er indiceret til behandling af aktiv psoriasis artrit hos voksne patienter, når svar på tidligere sygdomsmodificerende anti-reumatiske lægemidler (dmard) behandling har været mangelfuld. aksial spondyloarthritis (axspa)ankyloserende spondylitis (som, røntgen aksial spondyloarthritis)cosentyx er indiceret til behandling af aktiv ankyloserende spondylitis i voksne, der har reageret tilstrækkeligt til konventionel behandling. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Uniunea Europeană - daneză - EMA (European Medicines Agency)

serb sa - amifampridin - lambert-eaton myasthenic syndrom - andre narkotika stoffer - symptomatisk behandling af lambert-eaton myasthenisk syndrom (lems) hos voksne.

Uniunea Europeană - daneză - EMA (European Medicines Agency)

vanda pharmaceuticals netherlands b.v. - tasimelteon - søvnforstyrrelser, cirkadisk rytme - psykoleptika - hetlioz er indiceret til behandling af ikke-24-timers søvnvandsforstyrrelse (ikke-24) hos helt blinde voksne.

Uniunea Europeană - daneză - EMA (European Medicines Agency)

dendreon uk ltd - autologe perifere blodmononukleære celler indbefattende mindst 50 millioner autologe cd54 + -celler aktiveret med prostatasyre phosphatase granulocyt-makrofag kolonistimulerende faktor - prostatiske neoplasmer - andre immunstimulerende midler - provenge er indiceret til behandling af asymptomatiske eller minimalt symptomatisk metastatisk (ikke-visceral) kastreret-resistente prostatakræft i mandlige voksne i hvem kemoterapi ikke er endnu klinisk indiceret.

Uniunea Europeană - daneză - EMA (European Medicines Agency)

accord healthcare s.l.u. - zoledronsyremonohydrat - hypercalcemia; fractures, bone; cancer - bisfosfonater - forebyggelse af skeletrelaterede hændelser (patologiske frakturer, rygkompression, stråling eller operation til knogle eller tumorinduceret hypercalcæmi) hos voksne patienter med avancerede maligniteter, der involverer knogle. behandling af voksne patienter med tumor-induceret hypercalcaemia (tih).

Uniunea Europeană - daneză - EMA (European Medicines Agency)

actavis group ptc ehf   - zoledronsyremonohydrat - frakturer, knogler - narkotika til behandling af knoglesygdomme - forebyggelse af skeletrelaterede hændelser (patologiske frakturer, rygkompression, stråling eller operation til knogle eller tumorinduceret hypercalcæmi) hos voksne patienter med avancerede maligniteter, der involverer knogle. behandling af voksne patienter med tumor-induceret hypercalcaemia.