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

alexion europe sas - sebelipase alfa - lipid metabolisme, inborn fejl - andre alimentary tract and metabolism produkter, - kanuma er indiceret til langsigtet enzymbytningsbehandling (ert) hos patienter i alle aldre med lysosomalsyre lipase (lal) mangel.

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

alexion europe sas - asfotase alfa - hypophosphatasia - andre alimentary tract and metabolism produkter, - strensiq er indiceret til langsigtet enzymudskiftningsterapi hos patienter med hypofosfatasi i pediatrisk indtræden for at behandle sygdommens knoglesymboler..

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

alexion europe sas - eculizumab - hemoglobinuri, paroxysmal - immunosuppressiva - soliris er indiceret hos voksne og børn til behandling af:paroksysmal natlig haemoglobinuria (pnh). dokumentation af klinisk fordel er påvist hos patienter med haemolysis med klinisk symptom(er) betegnende for høj sygdomsaktivitet, uanset transfusion historie (se afsnit 5. atypiske hæmolytisk uræmisk syndrom (ahus). soliris er indiceret hos voksne til behandling af:ildfaste generaliseret myasthenia gravis (gmg) i patienter, der er anti-acetylcholin-receptor (achr) antistof-positive (se afsnit 5. neuromyelitis optica spektrum forstyrrelse (nmosd) i patienter, der er anti-aquaporin-4 (aqp4) antistof-positive med en recidiverende forløbet af sygdommen.

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.

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

elan pharma international ltd. - natalizumab - crohnsygdom - immunostimulants, - behandling af moderat til svær aktiv crohns sygdom for reduktion af tegn og symptomer, og induktion og vedligeholdelse af vedvarende respons og remission hos patienter, der ikke har reageret på trods af en fuld og dækkende løbet af behandling med binyrebarkhormon og immundæmpende, eller er intolerante over for eller har medicinske kontraindikationer til sådanne behandlinger.

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

biogen netherlands b.v. - natalizumab - multipel sclerose - selektive immunosuppressiva - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 og 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

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

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppressiva - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 og 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

stada arzneimittel ag - fluconazol - kapsler, hårde - 50 mg

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

boehringer ingelheim vetmedica gmbh - e. coli adhesin f4 (f4ab, f4ac, f4ad), e. coli adhesin f5, e. coli adhesin f6, e. coli adhesin f41 - immunologicals for suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - sows; sows (nullipar) - reduktion af neonatal enterotoxicosis af smågrise, der er forårsaget af e. coli-stammer, der udtrykker adhesinerne f4ab, f4ac, f4ad, f5, f6 og f41, i de første dage af livet.

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

ceva santé animale - clostridium perfringens type c, beta1 toxoid / clostridium perfringens, type a, alpha toxoid / clostridium perfringens, type a, beta2 toxoid / escherichia coli, fimbrial adhesin f4ab / escherichia coli, fimbrial adhesin f4ac / escherichia coli, fimbrial adhesin f5 / escherichia coli, fimbrial adhesin f6 - immunologicals for suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium - svin - for the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce:-           clinical signs (severe diarrhoea) and mortality caused by escherichia coli strains expressing the fimbrial adhesins f4ab, f4ac, f5 and f6-           clinical signs (diarrhoea during the first days of life) associated with clostridium perfringens type a expressing alpha and beta 2 toxins-           clinical signs and mortality associated with haemorrhagic and necrotising enteritis caused by clostridium perfringens type c expressing beta1 toxin.