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

bovela

boehringer ingelheim vetmedica gmbh - modificirane žive goveđa virusni proljev virus tipa 1, sobe-цитопатического roditeljske soja ke-9 i pms-om živi goveđa virusni proljev virus tipa 2, ne цитопатического roditeljske soja new york-93 - imunomodulatori za bika, živa virusna cjepiva - za aktivna imunizacija goveda od 3 mjeseca starosti, a za smanjenje гипертермии i kako bi se smanjili smanjenje broja bijelih krvnih stanica uzrokovana virusne dijareje goveda (bvdv-1 i bvdv-2), i smanjiti izlučivanje virusa i вирусемии uzrokovane bvdv-2. za aktivnu imunizaciju goveda protiv bvdv-1 i bvdv-2, kako bi se spriječilo nastanak uporno zarazenih teladi uzrokovanih transplacentalnom infekcijom.

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

ervebo

merck sharp & dohme b.v.  - рекомбинантный virus везикулярного стоматита (soj indiana) s brisanje koverti glikoprotein, zamijenjen zair ebole (soj киквите 1995) površinski glikoprotein - Геморрагическая groznice ebole - cjepiva - ervebo is indicated for active immunization of individuals 1 year of age or older to protect against ebola virus disease (evd) caused by zaire ebola virus. korištenje ervebo moraju biti u skladu sa službenim preporukama.

Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) Europska Unija - hrvatski - EMA (European Medicines Agency)

pandemic influenza vaccine h5n1 astrazeneca (previously pandemic influenza vaccine h5n1 medimmune)

astrazeneca ab - reassortant virus gripe (uživo oslabljenim) sljedeće soja: soja a/vijetnam/1203/2004 (h5n1) - gripa, ljudska - cjepiva - profilaksa influence u službeno deklariranoj pandemijskoj situaciji kod djece i adolescenata od 12 mjeseci do 18 godina starosti. cjepivo protiv pandemijskog gripa h5n1 АстраЗенека mora se koristiti u skladu sa službenim vodstvom.

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

qdenga

takeda gmbh - dengue virus, serotype 2, expressing dengue virus, serotype 1, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 3, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 4, surface proteins, live, attenuated, dengue virus, serotype 2, live, attenuated - denga - cjepiva - qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age. the use of qdenga should be in accordance with official recommendations.

Fluenz Tetra Europska Unija - hrvatski - EMA (European Medicines Agency)

fluenz tetra

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.

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

imlygic

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.

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

zalmoxis

molmed spa - alogenih t stanica genetski modificirani sa retrovirusni vektor kodiranje za skraćeni oblik ljudske nizak afinitet receptora faktora rasta živaca (Δlngfr) i herpes simplex virus timidin kinaze (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastična sredstva - zalmoksis je indiciran kao dodatna terapija u haploidentical hematopoetskih matičnih stanica (hsct) odraslih bolesnika s visokog rizika hematoloških malignih bolesti.

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

tecartus

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - limfom, mantel-stanica - antineoplastična sredstva - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

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

libmeldy

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - ostali lijekovi protiv živčanog sustava - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

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

skysona

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - ostali lijekovi protiv živčanog sustava - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.