Evrópusambandið - íslenska - EMA (European Medicines Agency)

janssen-cilag international n.v.   - bosentan (as monohydrate) - scleroderma, systemic; hypertension, pulmonary - háþiýstingslækkandi - meðferð á lungnaslagæðaháþrýstingi (pah) til að bæta æfingargetu og einkenni hjá sjúklingum með who virkni iii. efficacy has been shown in: , primary (idiopathic and familial) pah;, pah secondary to scleroderma without significant interstitial pulmonary disease;, pah associated with congenital systemic-to-pulmonary shunts and eisenmenger's physiology. , nokkrar endurbætur hafa líka verið sýnt fram í sjúklinga með pah sem hagnýtur ii. tracleer er einnig ætlað að fækka nýja stafræna sár í sjúklinga með almenna mænusigg og áframhaldandi stafræna magasár.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

biogen netherlands b.v. - dímetýl fúmarat - margvísleg sclerosis - Ónæmisbælandi lyf - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

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)

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)

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)

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).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

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

Evrópusambandið - íslenska - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - Ónæmisbælandi lyf - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

plusultra pharma gmbh - sirolimus - angiofibroma; tuberous sclerosis - hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.

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.