Evrópusambandið - íslenska - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - heila-og mænusigg, köstum tilkynnt - Ónæmisbælandi lyf - 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).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

krka, d.d., novo mesto - abirateron asetat - blöðruhálskirtli - innkirtla meðferð - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5. 1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

viiv healthcare b.v. - cabotegravir - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4. 2, 4. 4 og 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

n.v. organon - desloratadin - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - andhistamín fyrir almenn nota, - azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5. 1)urticaria (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

viiv healthcare b.v. - fostemsavir trometamol - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

tad pharma gmbh - clopidogrel (as hydrochloride) - peripheral vascular diseases; stroke; myocardial infarction - blóðþurrðandi lyf - clopidogrel is indicated in adults for the prevention of atherothrombotic events in: , patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

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)orpatients með ört vaxandi alvarlega köstum skil heila-og mænusigg skilgreind af 2 eða meira að slökkva köst í eitt ár, og með 1 eða meira skuggaefna efla sár á heilanum segulÓmun eða mikil aukning í t2 sár álag eins og miðað við fyrri undanförnum segulÓmun.

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)

amarin pharmaceuticals ireland limited - icosapent ethyl - dýrarannsóknir - lipid breytandi lyf - indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pfizer europe ma eeig - somatrogon - growth and development - sterum og undirstÚku hormÓn og hliÐstÆÐum - indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.