Kroazja - Kroat - HALMED (Agencija za lijekove i medicinske proizvode)

elektroničar d.o.o. karlovačka cesta 26/a 10000 zagreb -

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

alnylam netherlands b.v. - givosiran - Порфирий, zatajenje - različite dijelove probavnog trakta i metabolizma proizvodi - liječenje akutnog zatajenja порфирии (АХА) kod odraslih i adolescenata u dobi od 12 godina i stariji.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

qbiotics netherlands b.v. - tigilanol tiglate - tigilanol tiglate - psi - za liječenje neupotrebljiva, bez udaljenih metastaza (koji na pozornici) potkožnog pretilih stanica tumora, koji se nalazi na razini ili distalno na lakat ili skočnog zgloba kuka, i neupotrebljiva, sobe метастатические uzeli stanice kože рангоута tumora kod pasa.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant adenovirus type 26 (ad26) encoding the glycoprotein (gp) of the ebola virus zaire (zebov) mayinga strain - Геморрагическая groznice ebole - cjepiva - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp - Геморрагическая groznice ebole - cjepiva - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - tumori gastrointestinalnog stroma - drugi antitumorski lijekovi, inhibitori протеинкиназы - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

alnylam netherlands b.v. - lumasiran sodium - hyperoxaluria, primary - drugi gastrointestinalni trakt i metabolizam, lijekovi, - treatment of primary hyperoxaluria type 1 (ph1) in all age groups.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

insmed netherlands b.v. - amikacin sulfate - infekcije dišnih putova - antibakterijski lijekovi za sistemsku primjenu, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - cjepiva - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

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.