Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

biomedica dijagnostika d.o.o., zagreb - in vitro dijagnostika, identifikacija kodiranih alela s dnk uzorka

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi pasteur - influenza a virus subtype h1n1 haemagglutinin, recombinant, influenza a virus subtype h3n2 haemagglutinin, recombinant, influenza b virus victoria lineage haemagglutinin, recombinant, influenza b virus yamagata lineage haemagglutinin, recombinant - gripa, ljudska - cjepiva - supemtek is indicated for active immunization for the prevention of influenza disease in adults. supemtek should be used in accordance with official recommendations.

Europska Unija - hrvatski - EMA (European Medicines Agency)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - cjepiva - active immunisation against h5 subtype of influenza a virus.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hepatitis b, rekombinantni površinski antigen - hepatitis b; immunization - cjepiva - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. određene grupe rizika će biti cijepljeni moraju biti definirani na temelju službenih preporuka. može se očekivati da hepatitis d se također može spriječiti putem cijepljenja s hbvaxpro kao što su hepatitis d (uzrokovana agent delta) ne nalazi u nedostatku virusa hepatitis b infekcije. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. određene grupe rizika će biti cijepljeni moraju biti definirani na temelju službenih preporuka. može se očekivati da hepatitis d se također može spriječiti putem cijepljenja s hbvaxpro kao što su hepatitis d (uzrokovana agent delta) ne nalazi u nedostatku virusa hepatitis b infekcije. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. može se očekivati da hepatitis d također će spriječiti stvaranje imunizacije s hbvaxpro kao što su hepatitis d (uzrokovana agent delta) ne nalazi u nedostatku virusa hepatitisa b .

Europska Unija - hrvatski - EMA (European Medicines Agency)

intervet international bv - inaktivirani cijeli virus antigena ptičje gripe tipa h5n2 (vrsta a / patka / potsdam / 1402/86) - imunološki za aves - piletina - za aktivnu imunizaciju pilića protiv ptičje gripe tipa a, podtip h5. učinkovitost je ocijenjena na temelju preliminarnih rezultata u pilićima. smanjenje kliničkih znakova, smrtnosti i izolacije virusa nakon zaraze su pokazala tri tjedna nakon cijepljenja. očekuje se da će se serumska antitijela ustrajati barem 12 mjeseci nakon davanja dviju doza cjepiva.

Europska Unija - hrvatski - EMA (European Medicines Agency)

samsung bioepis nl b.v. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; hidradenitis suppurativa; arthritis - imunosupresivi - reumatoidni arthritisimraldi u kombinaciji s metotreksatom prikazana za:liječenje umjereni do teški, aktivan reumatoidni artritis kod odraslih pacijenata, kada odgovor na bolest-модифицирующих противоревматических lijekova, uključujući i metotreksat, bio je neadekvatno. tretman teških, aktivnog i uznapredovalog reumatoidnog artritisa kod odraslih, ne ranije liječenih metotreksat. imraldi može biti dano kao monoterapija u slučaju netolerancije метотрексата ili pri stalnom liječenju s metotreksat je nepraktično. Адалимумаб, kao što je prikazano, kako bi se smanjila brzina progresije oštećenja zglobova kao što se mjeri x-ray i poboljšati fizičku funkciju, prilikom raspoređivanja u kombinaciji s metotreksatom. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisimraldi in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. Адалимумаб ne ima dugu povijest u bolesnika u dobi od manje od 2 godine. enthesitis-related arthritisimraldi is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)imraldi is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of asimraldi is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). psorijatični arthritisimraldi indiciran za liječenje aktivnog i uznapredovalog psorijatični artritis kod odraslih, kad odgovor na prethodni заболевани-дорабатывая anti-reumatskih napitke terapija je bila neadekvatna.. adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5. 1) i poboljšati tjelesne funkcije. psoriasisimraldi indiciran za liječenje umjerene do teške kronične plak psorijaze kod odraslih pacijenata koji su kandidati za sistemske terapije. vrtić plak psoriasisimraldi indiciran za liječenje teških oblika kroničnog бляшечного psorijaze u djece i adolescenata od 4-ih godina, koji su imali neadekvatan odgovor ili neprikladne kandidate za lokalne liječenje i phototherapies. hidradenitis suppurativa (hs)imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 i 5. kruna diseaseimraldi indiciran za liječenje reumatoidnog crohnove bolesti, kod odraslih pacijenata koji se nisu odazvali, unatoč potpuni i odgovarajući tečaj terapija sa kortikosteroidima i/ili imunosupresivima, ili koji ne podnose ili imaju medicinske kontraindikacije za takvu terapiju. paediatric crohn's diseaseimraldi is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or haveulcerative colitisimraldi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitisimraldi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitisimraldi is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate. paediatric uveitisimraldi is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Hrvatska - hrvatski - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

ceva-phylaxia veterinary biologicals co. ltd., 1107 budapest, szállás u. 5., mađarska - živi, atenuirani metapneumovirus ptica (engl. avian metapneumovirus – ampv), podtip b, soj crr126 - liofilizat za suspenziju - imunološki proizvodi za ptice, domaća perad, živa virusna cjepiva - kokoši

Hrvatska - hrvatski - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

zoetis netherlands holdings b.v. podružnica zagreb za promidžbu, petra hektorovića 2, zagreb, hrvatska - inaktivirani virus leukemije mačaka (felv), podtipovi a, b i c (kawakami-theilen soj), koji uključuje subjedinični antigen (gp70) za poticanje tvorbe anti-gp70 protutijela - suspenzija za injekciju - mačaka (u dobi od 9 tjedana i više)

Europska Unija - hrvatski - EMA (European Medicines Agency)

dynavax gmbh - hepatitis b površinski antigen - hepatitis b - cjepiva - heplisav b is indicated for the active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes of hepatitis b virus in adults 18 years of age and older. the use of heplisav b should be in accordance with official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with heplisav b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

Hrvatska - hrvatski - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

ceva-phylaxia co. ltd., szállás u. 5., 1107 budimpešta, mađarska - živi, atenuirani metapneumovirus ptica (engl. avian metapneumovirus – ampv), podtip b, soj crr126 - liofilizat za suspenziju - kokoši