Evrópusambandið - íslenska - EMA (European Medicines Agency)

alexion europe sas - eculizumab - blóðrauði, ofsakláði - Ónæmisbælandi lyf - soliris er ætlað í fullorðna og börn fyrir meðferð:paroxysmal nóttu haemoglobinuria (pnh). sönnunargögn klínískum gagn er sýnt í sjúklinga með haemolysis með klínískum einkenni(s) marks um hár sjúkdómur starfsemi, óháð blóðgjöf sögu (sjá kafla 5. Óhefðbundin blóðlýsu uremic (ahus). soliris er ætlað í fullorðnir fyrir meðferð:svarar almenn vöðvaslensfár (gmg) í sjúklingum sem eru anti-asetýlkólíns viðtaka (achr) mótefni-jákvæð (sjá kafla 5. neuromyelitis optica svið röskun (nmosd) í sjúklingum sem eru anti-aquaporin-4 (aqp4) mótefni-jákvæð við köstum auðvitað sjúkdómsins.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - blóðrauði, ofsakláði - valdar ónæmisbælandi lyf - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

alexion europe sas - sebelipasa alfa - lipid efnaskipti, innfelldar villur - Önnur meltingarvegi og efnaskipti vörur, - kanuma er ætlað til langtímameðferð með ensímuppbótarmeðferð (ert) hjá sjúklingum á öllum aldri, með skort á lysósölt sýru lípasa (lal).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

alexion europe sas - asfotasa alfa - hypophosphatasia - Önnur meltingarvegi og efnaskipti vörur, - strensiq er ætlað til langtímameðferðar með ensímuppbótarmeðferð hjá sjúklingum með hypophosphatasia í upphafi meðferðar til að meðhöndla sjúkdóma í beinum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - Æxlishemjandi lyf - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

astrazeneca ab - andexanet alfa - lyfið-tengjast aukaverkanir og aukaverkanir - Öll önnur lækningavörur - fyrir fullorðna sjúklinga með bein þáttur xa (fxa) hemil (apixaban eða rivaroxaban) þegar viðsnúningur blóðþynningu er þörf vegna lífshættuleg eða stjórnlaus blæðingar.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - imepitoin - Önnur antiepileptics, antiepileptics - hundar - til að draga úr tíðni almennra krampa vegna sjálfsnæmisflogaveiki hjá hundum til notkunar eftir vandlega mat á öðrum meðferðarúrræðum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

incline therapeutics europe ltd - fentanýlhýdróklóríð - verkir, eftir aðgerð - verkjalyf - ionsys er ætlað til meðferðar við bráðum, miðlungsmiklum eða alvarlegum verkjum eftir fullorðna hjá fullorðnum sjúklingum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - Æxlishemjandi lyf - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

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.