Europska Unija - hrvatski - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - cjepiva - ambirix se upotrebljava u ne-imunim osobama od jedne godine do uključivo 15 godina za zaštitu od hepatitisa a i infekcije hepatitisa-b. zaštita od infekcije hepatitisa b ne mogu se dobiti samo nakon druge doze. stoga:ambirix treba koristiti samo onda kada postoji relativno nizak rizik tijekom tečaja cijepljenje za hepatitis b infekcije, preporučuje se ambirix treba propisati na mjestima gdje završetka doze tečaj cijepljenje mogu biti sigurni.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - prekursorska stanica limfoblastične leukemije-limfom - antineoplastična sredstva - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Europska Unija - hrvatski - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - antineoplastična sredstva - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - antineoplastična sredstva - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - multipli mijelom - antineoplastična sredstva - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - imunosupresivi - molimo pogledajte dokument s informacijama o proizvodu.

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

sanofi pasteur, 14 espace henry vallee, lyon, francuska - toksoid difterije toksoid tetanusa toksoid hripavca filamentozni hemaglutinin hripavca pertaktin hripavca fimbrijalni aglutinogeni hripavca 2 i 3 - suspenzija za injekciju u napunjenoj štrcaljki - 1 doza = 0,5 ml - urbroj: 1 doza (0,5 ml) sadrži: ≥ 2 iu (2 lf) toksoida difterije, ≥ 20 iu (5 lf) toksoida tetanusa, 2,5 µg toksoida hripavca, 5 µg filamentoznog hemaglutinina,3 µg pertaktina, 5 µg fimbrija tipova 2 i 3; adsorbirani na 1,5 mg aluminijevog fosfata (0,33 mg al)

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

sanofi pasteur s.a., 2 avenue pont pasteur, lyon, francuska - vaccinum дифтерии, pertusisa tetani fl, antigeni-o(s) minutum, adsorbatum - suspenzija za injekciju - 1 doza = 0,5 ml - urbroj: jedna doza (0,5 ml) sadrži: toksoid difterije ne manje od 2 iu (2 lf), toksoid tetanusa ne manje od 20 iu (5lf), antigene bakterije bordetella pertussis: toksoid hripavca 2,5 mikrograma, filamentozni hemaglutinin 5 mikrograma, pertaktin 3 mikrograma, fimbrije tipova 2 i 3 5 mikrograma, adsorbirani na aluminijev fosfat 1,5 mg (0,33 mg aluminija).

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - drugi antineoplastični agensi - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

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 .