Union européenne - islandais - EMA (European Medicines Agency)

sandoz gmbh - trastuzúmab - breast neoplasms; stomach neoplasms - Æxlishemjandi lyf - treatment of metastatic and early breast cancer and metastatic gastric cancer (mgc).

Union européenne - islandais - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizúmab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - Ónæmisbælandi lyf - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Union européenne - islandais - EMA (European Medicines Agency)

ucb pharma sa - certolizumab pegol - crohn disease - Ónæmisbælandi lyf - cimzia, in combination with methotrexate (mtx), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmard) including methotrexate, has been inadequate. Þegar hægt er að gefa eitt og sér í málið óþol stendur eða þegar áframhaldandi meðferð með stendur er óviðeigandi. cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.

Union européenne - islandais - EMA (European Medicines Agency)

eli lilly nederland b.v. - insúlín lispró - sykursýki - lyf notuð við sykursýki - fyrir meðferð fullorðna og börn með sykursýki sem þurfa insúlín til að viðhalda eðlilegt glúkósa homeostasis. liprolog er einnig ætlað til upphafs stöðugleika sykursýki.

Union européenne - islandais - EMA (European Medicines Agency)

novo nordisk a/s - mannainsúlín - sykursýki - lyf notuð við sykursýki - meðferð sykursýki.

Union européenne - islandais - EMA (European Medicines Agency)

biotest pharma gmbh - human hepatitis b immunoglobulin - immunization, passive; hepatitis b; liver transplantation - Ónæmiskerfið sera og mótefni, - fyrirbyggja lifrarbólgu b veira (hbv) aftur sýkingu í hbsag og hbv-dna neikvæð fullorðinn sjúklingar að minnsta kosti einn viku eftir lifrarígræðslu fyrir lifrarbólgu b völdum lifrarbilun. afbrigði hbv-dna ætti að vera staðfest innan síðustu 3 mánaða fyrir olt. sjúklingar ættu að vera hbsag neikvæðar áður en meðferð hefst. samhliða nota af fullnægjandi virostatic lyf ætti að vera talin standard lifrarbólgu b aftur sýkingu fyrirbyggja.

Islande - islandais - LYFJASTOFNUN (Icelandic Medicines Agency)

prothya biosolutions netherlands b.v. - immunoglobulinum humanum inn - innrennslislyf, lausn - 50 mg/ml

Union européenne - islandais - EMA (European Medicines Agency)

csl behring gmbh - human alpha1-proteinase inhibitor - genetic diseases, inborn; lung diseases - antihemorrhagics - respreeza er ætlað til viðhaldsmeðferðar, til að hægja á framvindu lungnaþembu hjá fullorðnum með skjölduðu alvarlega alfa1-próteínasa hemlaskort (e. arfgerðir pizz, piz (null), pi (null, null), pisz). sjúklingar skulu vera undir bestu lyfjafræðilegri og ekki lyfjameðferð og sýna fram á framsækna lungnasjúkdóm (e. neðri neydd útöndunarmagni á sekúndu (fev1) spáð, skert ganga getu eða fjölgun tilvikum) eins og metnar af heilbrigðisstarfsmaður reynslu í meðferð alpha1-próteinasa hemil skort.

Islande - islandais - LYFJASTOFNUN (Icelandic Medicines Agency)

csl behring gmbh* - human albumin - innrennslislyf, lausn - 200 g/l

Islande - islandais - LYFJASTOFNUN (Icelandic Medicines Agency)

csl behring gmbh* - human serum albumin - innrennslislyf, lausn - 50 g/l