Europos Sąjunga - kroatų - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd. - chlormethine - mycosis fungoides - antineoplastična sredstva - ledaga je indicirana za topičko liječenje limfoma t-stanica (tipa mf-tipa ctcl) tipa mikoza fungoida u bolesnika odraslih.

Europos Sąjunga - kroatų - EMA (European Medicines Agency)

biotest pharma gmbh - human hepatitis b immunoglobulin - immunization, passive; hepatitis b; liver transplantation - imuni serumi i homologna, - prevencija ponovne infekcije virusom hepatitisa b (hbv) u negativnim bolesnicima odraslih osoba hbsag i hbv-dna najmanje jedan tjedan nakon transplantacije jetre zbog hepatitisa b induciranog zatajivanja jetre. negativni status hbv-dna trebao bi se potvrditi u posljednja 3 mjeseca prije olt-a. bolesnici trebaju biti hbsag negativni prije početka liječenja. uz primjenu odgovarajućih agenata виростатического treba promatrati kao standard hepatitisa ponovno zaraze prevencija.

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

abiogen pharma s.p.a., via meucci 36, ospedaletto, pisa, italija - kolekalciferol - oralne kapi, otopina - urbroj: jedan ml oralnih kapi (40 kapi) sadrži 0,25 mg kolekalciferola (vitamina d3), što odgovara 10 000 iu jedna kap sadrži 0,00625 mg kolekalciferola (vitamina d3), što odgovara 250 iu

Europos Sąjunga - kroatų - EMA (European Medicines Agency)

immedica pharma ab - emedastine difumarate - konjunktivitis, alergijski - ophthalmologicals - simptomatsko liječenje sezonskog alergijskog konjunktivitisa.

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

piramal critical care b.v., rouboslaan 32, voorschoten, nizozemska - sevofluran - para inhalata, tekućina - 100 % - urbroj: jedna boca sadrži 250 ml sevoflurana

Europos Sąjunga - kroatų - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - takrolimus - odbacivanje transplantata - imunosupresivi - profilaksa odbacivanja transplantata kod odraslih primatelja bubrega ili jetrenih transplantata. liječenje odbacivanja alografta otpornih na liječenje drugim imunosupresivnim lijekovima u odraslih bolesnika.

Europos Sąjunga - kroatų - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - hiperkolesterolemija - sredstva za modifikaciju lipida - lojuxta je indicirana kao dodatak prehrani low‑fat i drugih lipid‑lowering lijekova s ili bez afereze najniža gustoće lipoproteina (ldl) u odraslih bolesnika s homozigotni obiteljska hiperkolesterolemija (hofh). genetičko potvrdu hofh mora biti ispitan na mogućnosti. drugi oblici primarne гиперлипопротейнемия i sekundarni uzroci гиперхолестеринемии (e. nephrotic sindrom, hipotireoza) moraju biti isključeni.

Europos Sąjunga - kroatų - EMA (European Medicines Agency)

roche registration gmbh - vemurafenib - melanoma - antineoplastična sredstva - vemurafenib je indiciran u monoterapiji za liječenje odraslih bolesnika s braf-v600-mutacijskim pozitivnim neosjetljivim ili metastatskim melanomom.

Europos Sąjunga - kroatų - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - imunosupresivi - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

a&b d.o.o., zagreb - određivanje klamidije