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

dechra regulatory b.v. - betamethasone acetate, terbinafine, florfenicol - kortikosteroider og antiinfectives i kombination - hunde - behandling af akut otitis ekstterna.

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

zoetis belgium sa - mavacoxib - anti inflammatorisk, og antireumatiske produkter - hunde - til behandling af smerte og betændelse forbundet med degenerativ leddssygdom hos hunde i tilfælde hvor kontinuerlig behandling på mere end en måned er angivet.

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

bayer ag  - vardenafil - erektil dysfunktion - urologicals - behandling af erektil dysfunktion hos voksne mænd. erektil dysfunktion er manglende evne til at opnå eller opretholde en penile erektion tilstrækkelig til tilfredsstillende seksuel ydeevne. for at levitra til at være effektiv, er seksuel stimulation er nødvendig. levitra er ikke indiceret til brug hos kvinder.

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

recordati rare diseases - zink - hepatolentikulær degeneration - andre alimentary tract and metabolism produkter, - behandling af wilsons sygdom.

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

zentiva, k.s. - pregabalin - anxiety disorders; epilepsy - antiepileptika, - neuropathic pain , pregabalin zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. , epilepsy , pregabalin zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. , generalised anxiety disorder , pregabalin zentiva is indicated for the treatment of generalised anxiety disorder (gad) in adults.

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

bayer ag  - vardenafil - erektil dysfunktion - urologicals - behandling af erektil dysfunktion hos voksne mænd. erektil dysfunktion er manglende evne til at opnå eller opretholde en penile erektion tilstrækkelig til tilfredsstillende seksuel ydeevne. for vivanza at være effektiv, er seksuel stimulation er nødvendig. vivanza er ikke indiceret til brug hos kvinder.

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

accord healthcare s.l.u. - lacosamid - epilepsi - antiepileptika, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 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.

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

amryt pharmaceuticals dac - metreleptin - lipodystrofi, familiær delvis - andre alimentary tract and metabolism produkter, - myalepta er indiceret som et supplement til kost som en substitutionsterapi til at behandle de komplikationer af leptin mangel i lipodystrofi (ld) patienter med bekræftet medfødte generelle ld (berardinelli-seip syndrom) eller erhvervet generelle ld (lawrence syndrom) hos voksne og børn på 2 år og abovewith bekræftet familiær delvis ld eller erhvervet, delvis ld (barraquer-simons syndrom), hos voksne og børn på 12 år og derover, for hvem standard-behandlinger har undladt at opnå tilstrækkelig metabolisk kontrol.

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

orphelia pharma sas - vigabatrin - spasms, infantile; epilepsies, partial - antiepileptika, - kigabeq er angivet i spædbørn og børn fra 1 måned til mindre end 7 år:behandling i monoterapi af infantile spasmer (west ' s syndrom). behandling i kombination med andre antiepileptiske lægemidler til patienter med resistent partiel epilepsi (fokale anfald) med eller uden sekundær generalisering, det er der, hvor alle andre relevante lægemiddel kombinationer har vist sig utilstrækkelig eller ikke tolereres.

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

alexion europe sas - ravulizumab - hemoglobinuri, paroxysmal - selektive immunosuppressiva - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.