Nucala Европска Унија - Исландски - EMA (European Medicines Agency)

nucala

glaxosmithkline trading services - mepolizumab - astma - lyf til veikindi öndunarvegi sjúkdómum, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Zeffix Европска Унија - Исландски - EMA (European Medicines Agency)

zeffix

glaxosmithkline (ireland) limited - lamivúdín - lifrarbólga b, langvarandi - veirueyðandi lyf til almennrar notkunar - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. upphaf áhrif meðferð ætti bara að vera talin þegar nota aðra veirum umboðsmaður með hærri erfðafræðilega hindrun er ekki í boði eða viðeigandi;, alvarleg lifrarsjúkdóm ásamt öðru umboðsmaður án kross-gegn áhrif.

Rotarix Европска Унија - Исландски - 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 Европска Унија - Исландски - 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 Европска Унија - Исландски - 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.

Trelegy Ellipta Европска Унија - Исландски - EMA (European Medicines Agency)

trelegy ellipta

glaxosmithkline trading services - flútíkasónfúróat, umeclidiniumbrómíð, vílanteróltrifenatat - lungnasjúkdómur, langvarandi hindrandi - lyf til veikindi öndunarvegi sjúkdómum, - trelegy ellipta er ætlað eins og viðhald í meðferð hjá fullorðnum með í meðallagi til alvarlega langvinn veikindi í lungum (llt) sem eru ekki nægilega meðhöndluð með sambland af andað barksteri og langverkandi β2-örva.

Zejula Европска Унија - Исландски - 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 Европска Унија - Исландски - 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 Европска Унија - Исландски - 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 Европска Унија - Исландски - 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.