Dectova Europska Unija - hrvatski - EMA (European Medicines Agency)

dectova

glaxosmithkline trading services limited - Занамивир - gripa, ljudska - antivirusni lijekovi za sustavnu uporabu - dectova indiciran za liječenje složene i potencijalno opasne gripe a ili b virusna infekcija kod odraslih i pedijatrijska bolesnika (u dobi ≥6 mjeseci), kada:bolesno virus gripe može biti otporan na противогриппозных lijekova, drugih, nego занамивир, i/ili antivirusnih lijekova za liječenje gripe, uključujući i ингаляционный занамивир, nisu pogodni za pojedinog pacijenta.. dectova mora se koristiti u skladu sa službenim vodstvom.

Blenrep Europska Unija - hrvatski - EMA (European Medicines Agency)

blenrep

glaxosmithkline (ireland) limited - belantamab mafodotin - multipli mijelom - antineoplastična sredstva - 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 Europska Unija - hrvatski - 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 Europska Unija - hrvatski - EMA (European Medicines Agency)

xevudy

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - imuni serumi i homologna, - 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.

Cervarix Europska Unija - hrvatski - EMA (European Medicines Agency)

cervarix

glaxosmithkline biologicals s.a. - tip osobe papillomavirus1 16 Л1 sirutke papilloma virus tipa 18 Л1 proteina - papillomavirus infections; uterine cervical dysplasia; immunization - cjepiva - cervarix je cjepivo namijenjeno u dobi od 9 godina za prevenciju premaligne ano-genitalnih lezija (vrata maternice, vulve, vaginalni i analni) i raka vrata maternice i analni uzročno povezan s određene onkogenih tipova humanog papiloma virusa (hpv). pogledajte odjeljke 4. 4 i 5. 1 za važne informacije o podacima koji podržavaju ovu oznaku. primjena Церварикс mora biti u skladu sa službenim preporukama.

Infanrix Hexa Europska Unija - hrvatski - EMA (European Medicines Agency)

infanrix hexa

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis b surface antigen, poliovirus (inactivated) (type-1 (mahoney strain), type-2 (mef-1 strain), type-3 (saukett strain)), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - cjepiva - infanrix hexa je indiciran za primarne i booster cijepljenje dojenčadi protiv difterije, tetanusa, protiv pertusisa, hepatitisa b, poliomijelitisa i bolesti uzrokovane haemophilus influenzae tip b.

Nucala Europska Unija - hrvatski - EMA (European Medicines Agency)

nucala

glaxosmithkline trading services - mepolizumab - astma - lijekovi za opstruktivne plućne bolesti dišnih putova, - 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 Europska Unija - hrvatski - EMA (European Medicines Agency)

zeffix

glaxosmithkline (ireland) limited - lamivudin - hepatitis b, kronični - antivirusni lijekovi za sustavnu uporabu - 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. početak liječenja lamivudinom mora biti samo u slučaju, ako se korištenje alternativnih antivirusnih agenata s višim genetski barijera nisu dostupni ili odgovarajući;, декомпенсированной bolesti jetre u kombinaciji s drugi agent bez križne rezistencije na lamivudin.

Rotarix Europska Unija - hrvatski - EMA (European Medicines Agency)

rotarix

glaxosmithkline biologicals s.a. - ljudski rotavirus, živi atenuiran - immunization; rotavirus infections - cjepiva - rotarix je indiciran za aktivnu imunizaciju dojenčadi u dobi od 6 do 24 tjedna za prevenciju gastroenteritisa izazvanog infekcijom rotavirusom. korištenje izvedbe nema statističke značajnosti treba se osloniti na službene preporuke.

Synflorix Europska Unija - hrvatski - 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 - cjepiva - aktivna imunizacija protiv invazivnih bolesti i akutnih otitis media uzrokovanih streptococcus pneumoniae kod dojenčadi i djece od šest tjedana do pet godina. pogledajte odjeljke 4. 4 i 5. 1 u informacijama o proizvodu za informacije o zaštiti od specifičnih pneumokoknih serotipova. primjena cjepivo synflorix mora odrediti na temelju službenih preporuka, uzimajući u obzir utjecaj invazivne bolesti u različitim dobnim skupinama, kao i varijabilnost серотип za epidemiologiju u različitim zemljopisnim područjima.