Evrópusambandið - íslenska - EMA (European Medicines Agency)

gilead sciences ireland uc - bulevirtide acetate - hepatitis d, chronic - veirueyðandi lyf til almennrar notkunar - hepcludex is indicated for the treatment of chronic hepatitis delta virus (hdv) infection in plasma (or serum) hdv-rna positive adult patients with compensated liver disease.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

cis bio international - ioflupan (123l) - radionuclide imaging; dementia; movement disorders - greining geislavirkja - Þetta lyf er eingöngu ætlað til greiningar. striascan er ætlað til greina tap hagnýtur dopaminergic taugafruma tengjum í striatum:Í fullorðinn sjúklinga með vísindalega óvíst parkinsonian heilkenni, til dæmis þá með snemma einkenni, í röð til að hjálpa greina nauðsynlegt skjálfti frá parkinsonian heilkennum tengjast sjálfvakin parkinsonsveiki, margar kerfi visnun og framsækið supranuclear lömun. striascan er ófær um að mismuna parkinsonsveiki, margar kerfi visnun og framsækið supranuclear lömun. Í fullorðinn sjúklingar, til að hjálpa greina líklega með heilabilun lewy líkama frá alzheimer. striascan er ófær um að mismuna heilabilun með lewy líkama og parkinsonsveiki heilabilun.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp - blæðandi hiti, ebóla - bóluefni - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - bóluefni - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. notkun þetta bóluefni ætti að vera í samræmi við opinbera tillögur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - deucravacitinib - psoriasis - Ónæmisbælandi lyf - treatment of moderate-to-severe plaque psoriasis in adults.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ucb pharma s.a.   - rotigótín - restless legs syndrome; parkinson disease - anti-parkinsonslyf - leganto er ætlað til meðferðar við meðhöndlun á meðallagi til alvarlega sjálfvakta eirðarleysi og fótaheilkenni hjá fullorðnum. leganto er ætlað fyrir meðferð einkenni snemma-stigi sjálfvakin parkinsonsveiki eitt og sér (ég. án levodopa) eða í samsettri meðferð með levodopa, i. á meðan á sjúkdómur, í gegnum að seint á stigum þegar áhrif algengari líður burt eða verður það í ósamræmi og sveiflur á verkun komið (lok skammt eða 'á-burt' sveiflur).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ucb pharma s.a. - rotigótín - restless legs syndrome; parkinson disease - anti-parkinsonslyf - parkinsonsveiki: neupro er ætlað til meðferðar á einkennum parkinsonsveiki í upphafi stigs einlyfja meðferð sem einlyfjameðferð (i. án levodopa) eða í samsettri meðferð með levodopa, i. á meðan á sjúkdómnum stendur, í gegnum seint stig þegar áhrif levodopa ganga frá eða verða ósamrýmanleg og sveiflur á meðferðaráhrifum eiga sér stað (lokaskammtur eða "á-burt" sveiflur). eirðarlaus-fætur heilkenni: neupro er ætlað fyrir einkennum meðferð í meðallagi til alvarlega sjálfvakin eirðarlaus-fætur heilkenni í fullorðnir.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ge healthcare b.v. - ioflupan (123l) - tomography, emission-computed, single-photon; lewy body disease; parkinson disease; alzheimer disease - greining geislavirkja - Þetta lyf er eingöngu ætlað til greiningar. datscan er ætlað til greina tap hagnýtur dopaminergic taugafruma tengjum í striatum:Í fullorðinn sjúklinga með vísindalega óvíst parkinsonian heilkenni, til dæmis þá með snemma einkenni, í röð til að hjálpa greina nauðsynlegt skjálfti frá parkinsonian heilkennum tengjast sjálfvakin parkinsonsveiki, margar kerfi visnun og framsækið supranuclear lömun. datscan er ófær um að mismuna parkinsonsveiki, margar kerfi visnun og framsækið supranuclear lömun. Í fullorðinn sjúklingar, til að hjálpa greina líklega með heilabilun lewy líkama frá alzheimer. datscan er ófær um að mismuna heilabilun með lewy líkama og parkinsonsveiki heilabilun.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

gilead sciences ireland uc, galapagos nv - filgotinib maleate - liðagigt, liðagigt - Ónæmisbælandi lyf - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.