Europeiska unionen - svenska - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuri, paroxysmal - selektiva immunsuppressiva medel - 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

elan pharma international ltd. - natalizumab - crohnsjukdom - immunstimulatorer, - behandling av måttlig till svår aktiv crohns sjukdom för minskning av tecken och symtom, och induktion och underhåll av varaktig respons och remission, i patienter som inte har svarat trots fullständig och adekvat naturligtvis av behandling med en kortikosteroid och en immunosuppressant, eller som är intoleranta eller har medicinska kontraindikationer för sådana behandlingar.

Europeiska unionen - svenska - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - multipel skleros - selektiva immunsuppressiva medel - 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 och 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunsuppressiva - 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 och 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

laboratorios lesvi s.l. - dimetylfumarat - multipel skleros, skovvis förlöpande - immunsuppressiva - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Europeiska unionen - svenska - EMA (European Medicines Agency)

astrazeneca ab - palivizumab - respiratoriska syncytialvirusinfektioner - immunförsvaret sera och immunglobuliner, - synagis är indicerat för prevention av allvarliga nedre luftvägarna sjukdomar som kräver sjukhusvård orsakad av respiratoriskt syncytialvirus (rsv) hos barn med hög risk för rsv-sjukdom:barn födda på 35 veckor av dräktigheten eller mindre och mindre än sex månaders ålder vid debut av rsv-säsongen;barn som är kortare än två år och som kräver behandling för bronchopulmonary dysplasia inom de senaste sex månader. barn som är kortare än två år och med hemodynamiskt signifikant kongenital hjärtsjukdom.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

amarox pharma gmbh - fingolimodhydroklorid - kapsel, hård - 0,5 mg - fingolimodhydroklorid 0,56 mg aktiv substans; propylenglykol hjälpämne; natriumlaurilsulfat hjälpämne

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

aristo pharma gmbh - fingolimodhydroklorid - kapsel, hård - 0,5 mg - natriumlaurilsulfat hjälpämne; fingolimodhydroklorid 0,56 mg aktiv substans; propylenglykol hjälpämne

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

medical valley invest ab - fingolimodhydroklorid - kapsel, hård - 0,5 mg - fingolimodhydroklorid 0,56 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

unimedic pharma ab - fingolimodhydroklorid - kapsel, hård - 0,5 mg - fingolimodhydroklorid 0,56 mg aktiv substans