Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan ireland limited - fingolimod stutt og long-term - heila-og mænusigg, köstum tilkynnt - Ónæmisbælandi lyf - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - Ónæmisbælandi lyf - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

biogen netherlands b.v. - natalízúmab - margvísleg sclerosis - valdar ónæmisbælandi lyf - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sandoz gmbh - natalízúmab - multiple sclerosis, relapsing-remitting; multiple sclerosis - Ónæmisbælandi lyf - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ozanimod stutt og long-term - multiple sclerosis, relapsing-remitting; colitis, ulcerative - Ónæmisbælandi lyf - multiple sclerosiszeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features. ulcerative colitiszeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan ireland limited - dímetýl fúmarat - heila-og mænusigg, köstum tilkynnt - Ónæmisbælandi lyf - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

zaklady farmafarmaceutyczne polpharma s.aceutyczne polpharma s.a. - dímetýl fúmarat - heila-og mænusigg, köstum tilkynnt - Ónæmisbælandi lyf - dimethyl fumarate polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

laboratorios lesvi s.l. - dímetýl fúmarat - heila-og mænusigg, köstum tilkynnt - Ónæmisbælandi lyf - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psoriasis - Ónæmisbælandi lyf - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

teva gmbh - dímetýl fúmarat - multiple sclerosis, relapsing-remitting; multiple sclerosis - Ónæmisbælandi lyf - dimethyl fumarate teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).