สหภาพยุโรป -
โครเอเชีย -
EMA (European Medicines Agency)
tecovirimat siga
siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirusni lijekovi za sustavnu uporabu - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 i 5. tecovirimat siga should be used in accordance with official recommendations.
สหภาพยุโรป -
โครเอเชีย -
EMA (European Medicines Agency)
neorecormon
roche registration gmbh - epoetin beta - kidney failure, chronic; anemia; cancer; blood transfusion, autologous - antianemijski pripravci - liječenje simptomatske anemije, povezane s kroničnom bubrežnom insuficijencijom (crf) i педиатрические pacijenti odrasla osoba;liječenje simptomatske anemije kod odraslih pacijenata s миелоидными maligna новообразованиями primaju kemoterapiju;povećanje prinosa аутокрови kod bolesnika u pre-дарственной programa. njegova upotreba u ovoj brojila moraju biti уравновешены je obaviješten o povećanju rizika тромбоэмболических komplikacija . liječenje bi trebalo biti dano samo za bolesnike s umjerenom anemičan (persopn 10 - 13 g/dl [6. 21 - 8. 07 mmol/l], bez nedostatka željeza), ako je postupak spremanja krvi nema ili je nedovoljna za planirani veliki planska operacija zahtijeva velike količine krvi (4 i više jedinica krvi za žene ili 5 ili više jedinica za muškarce).
สหภาพยุโรป -
โครเอเชีย -
EMA (European Medicines Agency)
kalydeco
vertex pharmaceuticals (ireland) limited - ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 i 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 i 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.
สหภาพยุโรป -
โครเอเชีย -
EMA (European Medicines Agency)
silodosin recordati
recordati ireland ltd - silodosin - prostata hyperplasia - urologicals, alfa-antagonisti адренорецепторов - liječenje znakova i simptoma benigne простатической hiperplazija (bph) kod muškaraca u dobi od.