Rotarix Den europeiske union - islandsk - EMA (European Medicines Agency)

rotarix

glaxosmithkline biologicals s.a. - manna rotavirus, lifandi dregið úr - immunization; rotavirus infections - bóluefni - rotarix er ætlað til virkrar ónæmis hjá ungabörnum á aldrinum 6 til 24 vikna til að koma í veg fyrir magabólgu vegna rotavirus sýkingar. notkun rotarix ætti að vera byggt á opinberum meðmæli.

Synflorix Den europeiske union - islandsk - EMA (European Medicines Agency)

synflorix

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - bóluefni - virkt ónæmisaðgerðir gegn innrásarsjúkdómum og bráðum miðtaugabólgu af völdum streptococcus pneumoniae hjá ungbörnum og börnum frá sex vikum upp í fimm ára aldur. sjá kafla 4. 4 og 5. 1 í upplýsingum um vörur til að fá upplýsingar um vernd gegn tilteknum sermigerðum pneumokokkum. notkun synflorix ætti að vera ákveðin á grundvelli opinbera tillögur að taka tillit áhrif innrásar sjúkdóminn í mismunandi aldri tekur eins og l serotype faraldsfræði í mismunandi landsvæðum.

Volibris Den europeiske union - islandsk - EMA (European Medicines Agency)

volibris

glaxosmithkline (ireland) limited - ambrisentan - háþrýstingur, lungnabólga - háþiýstingslækkandi - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

Zejula Den europeiske union - islandsk - EMA (European Medicines Agency)

zejula

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - Æxlishemjandi lyf - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Shingrix Den europeiske union - islandsk - EMA (European Medicines Agency)

shingrix

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e - ristil - bóluefni - shingrix is indicated for prevention of herpes zoster (hz) and post-herpetic neuralgia (phn), in:adults 50 years of age or older;adults 18 years of age or older at increased risk of hz. notkun shingrix ætti að vera í samræmi við opinbera tillögur.

Dectova Den europeiske union - islandsk - EMA (European Medicines Agency)

dectova

glaxosmithkline trading services limited - zanamivír - inflúensu, manna - veirueyðandi lyf til almennrar notkunar - dectova er ætlað fyrir meðferð flókið og lífshættulegt inflúensu a eða b veiru-sýkingu í fullorðna og börn sjúklingar (aldrinum stærri 6 mánuðum) þegar:sjúklings inflúensu veira er vitað eða grunur leikur á að vera þola anti-inflúensu lyf annað en zanamivír, og/eðaannað gegn friðhelgi lyf fyrir meðferð inflúensu, þar á meðal andað zanamivír, eru ekki við hæfi fyrir sjúkling. dectova ætti að vera notuð í samræmi við opinbera leiðsögn.

Blenrep Den europeiske union - islandsk - EMA (European Medicines Agency)

blenrep

glaxosmithkline (ireland) limited - belantamab mafodotin - mergæxli - Æxlishemjandi lyf - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Jemperli Den europeiske union - islandsk - EMA (European Medicines Agency)

jemperli

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

Xevudy Den europeiske union - islandsk - EMA (European Medicines Agency)

xevudy

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - Ónæmiskerfið sera og mótefni, - xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (covid-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe covid-19.

Anoro Ellipta (previously Anoro) Den europeiske union - islandsk - EMA (European Medicines Agency)

anoro ellipta (previously anoro)

glaxosmithkline (ireland) limited - skert umbrot brómíð, trifenatate. - lungnasjúkdómur, langvarandi hindrandi - lyf til veikindi öndunarvegi sjúkdómum, - Þar ellipta er ætlað sem viðhald berkjuvíkkandi meðferð til að létta einkenni í fullorðinn sjúklinga með langvinn veikindi í lungum (llt).