Europska Unija - hrvatski - EMA (European Medicines Agency)

medimmune llc - Реассортанта virusa gripe (live аттенуированная) sljedećih sojeva:a/california/7/2009 pdm09 (Н1n1)kao soj a/victoria/361/2011 (Н3n2), kao što su napon, b/ma/2/2012 kao soj - influenza, human; immunization - cjepiva - profilaksa gripe kod osoba od 24 mjeseca do 18 godina starosti. korištenje fluenz mora se temeljiti na službenim preporukama.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astrazeneca ab - a/darwin/9/2021 (h3n2) - like strain (a/norway/16606/2021, medi 355293) / a/victoria/2570/2019 (h1n1)pdm09 - like strain (a/victoria/1/2020, medi 340505) / b/austria/1359417/2021 - like strain (b/austria/1359417/2021, medi 355292) / b/phuket/3073/2013 - like strain (b/phuket/3073/2013, medi 306444) - gripa, ljudska - cjepivo protiv gripe, gripa, živa аттенуированная - prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. upotreba fluenz tetra trebala bi se temeljiti na službenim preporukama.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - talimogene laherparepvec - melanoma - antineoplastična sredstva - imlygic je indiciran za liječenje odraslih s inoperabilnim melanom koji je regionalno ili najudaljenijim metastatski (stage iiib, iiic i ivm1a) nema kosti, mozak, pluća ili drugih visceralne bolesti.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international n.v. - telaprevir - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - incivo, u kombinaciji sa peg interferonom alfa i ribavirinom, indiciran za liječenje genotip 1 kroničnog hepatitisa c kod odraslih pacijenata s компенсированным bolesti jetre (uključujući cirozu):koji je tretman naivan, koji je ranije liječenje interferonom alfa (пегилированным ili пегилированным) kao monoterapija ili u kombinaciji sa ribavirinom, uključujući i recidiv, djelomični okrivljenika i неответчики.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international nv - Этравирин - hiv infekcije - non-nucleoside reverse transcriptase inhibitors, antivirals for systemic use - intelence, u kombinaciji s jačanju proteaze i druge antiretrovirusne lijekove, je indiciran za liječenje ljudskih-imunodeficijencije-virus-tip-1 (hiv-1) infekcije u odraslih bolesnika s antiretrovirusne liječeni i antiretrovirusne liječeni pedijatrijskih bolesnika od šest godina. ovaj prikaz se temelji na tjedan-48 analize dvije faze iii kliničkih ispitivanja vrhunski obučena pacijenata, gdje Интеленс proučavan je u kombinaciji s optimiziranim sheme (arr), koja je uključivala дарунавир/ritonavir. napomena u pedijatrijskoj oboljelih se temelji na 48-tjedan analiza jednom rukom, u drugoj fazi suđenja u arv-liječenje-iskusan pedijatrijska bolesnika.

Europska Unija - hrvatski - EMA (European Medicines Agency)

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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - carfilzomib - multipli mijelom - antineoplastična sredstva - kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - cinakalcet hidroklorid - hypercalcemia; parathyroid neoplasms; hyperparathyroidism - homeostaza kalcija - sekundarni hyperparathyroidismadultstreatment sekundarni hiperparatireoidizam (atg) u odraslih bolesnika s terminala bubrega (esrd) na održavanje диализной terapija. vrtić populationtreatment sekundarni hiperparatireoidizam (atg) u djece u dobi od 3 godina i stariji sa terminala fazi zatajenja bubrega (ТХПН) na održavanje диализной terapije, u kojem sekundarni atg ispravno ne prati standard medicinske terapije. mimpara može se koristiti kao dio zdravstvenog stanja, uključujući i fosfatnih veziva i/ili vitamina d, steroli, po potrebi. karcinom parathyroid žlijezde i primarni hiperparatireoidizam kod odraslih. pad гиперкальциемии kod odraslih pacijenata s:паратиреоидная karcinom;glavni ТВД za koje паратиреоидэктомия će biti drugačije, na temelju razine kalcija u serumu (kao što je definirano u relevantnim smjernicama za liječenje), ali u kojima паратиреоидэктомия nije klinički ili je kontraindicirano.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - pegfilgrastim - neutropenia; cancer - Иммуностимуляторы, - smanjenje duljine trajanja neutropenije i incidencije febrilne neutropenije u bolesnika liječenih citotoksičnom kemoterapijom zbog zloćudne bolesti (uz iznimku kronične mijeloične leukemije i mijelodisplastičnog sindroma).