Den europeiske union - norsk - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - multippel sklerose, relapsing-remitting - immunsuppressive - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 og 5. 1)orpatients med raskt utviklende alvorlig relapsing remitting multippel sklerose definert ved 2 eller flere deaktivere tilbakefall i ett år, og med 1 eller flere gadolinium å styrke lesjoner på brain mr eller en betydelig økning i t2 lesjon legg i forhold til en tidligere nyere mr.

Den europeiske union - norsk - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - multippel sklerose, relapsing-remitting - immunsuppressive - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Den europeiske union - norsk - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - multippel sklerose, relapsing-remitting - immunsuppressive - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (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 europeiske union - norsk - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - avacopan - microscopic polyangiitis; wegener granulomatosis - immunsuppressive - tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa).

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinuri, paroksysmal - immunsuppressive - aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who are anaemic after treatment with a c5 inhibitor for at least 3 months.

Den europeiske union - norsk - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus erythematosus, systemisk - immunsuppressive - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.

Den europeiske union - norsk - EMA (European Medicines Agency)

mylan ireland limited - dimetylfumarat - multippel sklerose, relapsing-remitting - immunsuppressive - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Den europeiske union - norsk - EMA (European Medicines Agency)

zaklady farmafarmaceutyczne polpharma s.aceutyczne polpharma s.a. - dimetylfumarat - multippel sklerose, relapsing-remitting - immunsuppressive - dimethyl fumarate polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Den europeiske union - norsk - EMA (European Medicines Agency)

axunio pharma gmbh - pirfenidone - idiopatisk lungefibrose - immunsuppressive - pirfenidone aet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Den europeiske union - norsk - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - immunsuppressive - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.