Nucala Union européenne - français - EMA (European Medicines Agency)

nucala

glaxosmithkline trading services - mepolizumab - asthme - les médicaments pour les maladies respiratoires obstructives, - 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 Union européenne - français - EMA (European Medicines Agency)

zeffix

glaxosmithkline (ireland) limited - lamivudine - hépatite b chronique - antiviraux à usage systémique - 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. l'initiation du traitement à la lamivudine ne doit être considéré lors de l'utilisation d'un autre agent antiviral avec une augmentation de la génétique de la barrière n'est pas disponible ou adaptée;, une maladie hépatique décompensée en combinaison avec un deuxième agent sans résistance croisée à la lamivudine.

Synflorix Union européenne - français - 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 - vaccins - immunisation active contre la maladie invasive et l'otite moyenne aiguë causée par streptococcus pneumoniae chez les nourrissons et les enfants de six semaines à cinq ans. voir les sections 4. 4 et 5. 1 dans les informations sur le produit pour des informations sur la protection contre les sérotypes pneumococciques spécifiques. l'utilisation de synflorix devrait être déterminé sur la base des recommandations officielles en tenant compte de l'incidence de la maladie invasive dans les différents groupes d'âge ainsi que de la variabilité de sérotype de l'épidémiologie dans les différentes zones géographiques.

Volibris Union européenne - français - EMA (European Medicines Agency)

volibris

glaxosmithkline (ireland) limited - ambrisentan - hypertension pulmonaire - antihypertenseurs, - 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 Union européenne - français - EMA (European Medicines Agency)

zejula

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - agents antinéoplasiques - 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.

Alpha-Rix susp. inj. i.m./s.c. ser. préremplie Belgique - français - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

alpha-rix susp. inj. i.m./s.c. ser. préremplie

glaxosmithkline biologicals sa-nv - virus influenza inactivé - suspension injectable - virus influenza inactivé - influenza, inactivated, split virus or surface antigen

Hiberix 10 µg/0.5 ml sol. inj. (pdr. + solv.) i.m. flac. + amp. + ser. préremplie Belgique - français - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

hiberix 10 µg/0.5 ml sol. inj. (pdr. + solv.) i.m. flac. + amp. + ser. préremplie

glaxosmithkline biologicals sa-nv - polyosides d'haemophilus influenzae type b conjugués à l’anatoxine tétanique 10 /0,5 35 µg/dose (of wich 10 µg polysaccharide haemophilus influenzae type b and about 25 µg tetanus toxine (tt)) - poudre et solvant pour solution injectable - 10 µg/0.5 ml - polyosides d'haemophilus influenzae type b conjugués à l’anatoxine tétanique - hemophilus influenzae b, purified antigen conjugated

Blenrep Union européenne - français - EMA (European Medicines Agency)

blenrep

glaxosmithkline (ireland) limited - belantamab mafodotin - le myélome multiple - agents antinéoplasiques - 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 Union européenne - français - 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 Union européenne - français - EMA (European Medicines Agency)

xevudy

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - des sérums et immunoglobulines, - 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.