Modigraf Evrópusambandið - íslenska - EMA (European Medicines Agency)

modigraf

astellas pharma europe b.v. - takrólímus - graft rejection - Ónæmisbælandi lyf - fyrirbyggjandi meðferð við höfnun ígræðslu hjá fullorðnum og börnum, nýrna-, lifrar- eða hjartaþegum. meðferð ígrædd nýru höfnun þola meðferð með öðrum ónæmisbælandi lyf í fullorðna og börn sjúklingar.

Modifenac Hart hylki með breyttan losunarhraða 75 mg Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

modifenac hart hylki með breyttan losunarhraða 75 mg

teva b.v.* - diclofenacum natríum - hart hylki með breyttan losunarhraða - 75 mg

Comirnaty Evrópusambandið - íslenska - EMA (European Medicines Agency)

comirnaty

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.

ChondroCelect Evrópusambandið - íslenska - EMA (European Medicines Agency)

chondrocelect

tigenix n.v. - einkennist af raunhæfum sjálfkrafa brjóskum sem stækkuð eru ex vivo sem tjá sértæka próteinprótein - brjóskasjúkdómar - Önnur lyf við sjúkdómum í stoðkerfi - viðgerð á einkennandi brjóskgalla í lærleggsþekju hnésins (international creation repair society [icrs] iii eða iv) hjá fullorðnum. samhliða einkennalaus brjósk sár (icrs bekk ég eða ii) gæti verið til staðar. sönnun á virkni er byggt á slembiraðaði stjórnað prufa að meta verkun chondrocelect í sjúklinga með sár á milli 1 og 5 cm2.

Holoclar Evrópusambandið - íslenska - EMA (European Medicines Agency)

holoclar

holostem s.r.l - ex vivo stækkaðar, sjálfstæðar glæruþekjufrumur úr mönnum sem innihalda stofnfrumur - stem cell transplantation; corneal diseases - augnlækningar - meðferð fullorðinn sjúklinga með í meðallagi til alvarlega limbal stafa klefi skort (skilgreind af nærveru yfirborðskennd hornhimnu neovascularisation í að minnsta kosti tvo hornhimnu quadrants, með mið hornhimnu þátttöku, og alvarlega skert sjón), einhliða eða tvíhliða, vegna þess að líkamlegri eða efna augu brennur. að lágmarki 1-2 mm2 af óskemmdum limbus er krafist fyrir sýnatöku.

Maci Evrópusambandið - íslenska - EMA (European Medicines Agency)

maci

vericel denmark aps - autologous cultured chondrocytes - brot, brjósk - Önnur lyf við sjúkdómum í stoðkerfi - viðgerðir á brjóskum á brjósti á einkennum.

Alofisel Evrópusambandið - íslenska - EMA (European Medicines Agency)

alofisel

takeda pharma a/s - darvadstrocel - endaþarm notast - Ónæmisbælandi lyf - alofisel er ætlað fyrir meðferð flókið endaþarminum fistulas í fullorðinn sjúklinga með ekki-virk/dálítið virk luminal crohn-sjúkdóm, þegar fistulas hafa sýnt ófullnægjandi svar að minnsta kosti einn hefðbundnum eða líffræðileg meðferð. alofisel ætti að nota eftir ástand notast.

Breyanzi Evrópusambandið - íslenska - EMA (European Medicines Agency)

breyanzi

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - Æxlishemjandi lyf - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Mvabea Evrópusambandið - íslenska - EMA (European Medicines Agency)

mvabea

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.

Onureg Evrópusambandið - íslenska - EMA (European Medicines Agency)

onureg

bristol-myers squibb pharma eeig - azasitidín - kyrningahvítblæði, mergbólga, bráð - Æxlishemjandi lyf - onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (aml) who achieved complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (hsct).