Rotarix Den Europæiske Union - dansk - EMA (European Medicines Agency)

rotarix

glaxosmithkline biologicals s.a. - human rotavirus, levende svækket - immunization; rotavirus infections - vacciner - rotarix er indiceret til aktiv immunisering af spædbørn i alderen 6 til 24 uger til forebyggelse af gastroenteritis på grund af rotavirusinfektion. brug af rotarix bør være baseret på officielle anbefaling.

Synflorix Den Europæiske Union - dansk - 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 - vacciner - aktiv immunisering mod invasiv sygdom og akut otitismedium forårsaget af streptococcus pneumoniae hos spædbørn og børn fra seks uger til fem år. se afsnit 4. 4 og 5. 1 i produktinformationen for oplysninger om beskyttelse mod specifikke pneumokok serotyper. brug af synflorix bør fastsættes på grundlag af de officielle anbefalinger, der tager højde for den effekt af invasiv sygdom i forskellige aldersgrupper, samt variation af serotype epidemiologi i forskellige geografiske områder.

Volibris Den Europæiske Union - dansk - EMA (European Medicines Agency)

volibris

glaxosmithkline (ireland) limited - ambrisentan - hypertension, lunge - antihypertensiva, - 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 Europæiske Union - dansk - EMA (European Medicines Agency)

zejula

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastiske midler - 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 Europæiske Union - dansk - EMA (European Medicines Agency)

shingrix

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e - herpes zoster - vacciner - 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. brug af shingrix bør være i overensstemmelse med de officielle anbefalinger.

Dectova Den Europæiske Union - dansk - EMA (European Medicines Agency)

dectova

glaxosmithkline trading services limited - zanamivir - influenza, human - antivirale midler til systemisk anvendelse - dectova er indiceret til behandling af komplicerede og potentielt livstruende influenza a-eller b-virus-infektion hos voksne og pædiatriske patienter (i alderen ≥6 måneder), når:patientens influenza-virus er kendt for eller mistænkt for at være resistente over for anti-influenza andre lægemidler end zanamivir, og/orother anti-virale lægemidler til behandling af influenza, herunder indånding zanamivir, er ikke egnet til den enkelte patient. dectova bør anvendes i overensstemmelse med officielle retningslinjer.

Blenrep Den Europæiske Union - dansk - EMA (European Medicines Agency)

blenrep

glaxosmithkline (ireland) limited - belantamab mafodotin - multipelt myelom - antineoplastiske midler - 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 Europæiske Union - dansk - 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 Europæiske Union - dansk - EMA (European Medicines Agency)

xevudy

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - immune sera og immunoglobuliner, - 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 Europæiske Union - dansk - EMA (European Medicines Agency)

anoro ellipta (previously anoro)

glaxosmithkline (ireland) limited - umeclidinium bromid, vilanterol trifenatate - pulmonal sygdom, kronisk obstruktiv - medicin for obstruktiv sygdomme, - anoro ellipta er anført som vedligeholdelse bronkodilaterende behandling til at lindre symptomer i voksne patienter med kronisk obstruktiv lungesygdom (kol).