Euroopan unioni - norja - 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).

Euroopan unioni - norja - 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.

Euroopan unioni - norja - 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).

Euroopan unioni - norja - 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.

Euroopan unioni - norja - 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.

Euroopan unioni - norja - 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.

Euroopan unioni - norja - 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.

Euroopan unioni - norja - 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).

Euroopan unioni - norja - 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.

Euroopan unioni - norja - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - immunsuppressive - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).