Európska únia - chorvátčina - 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.

Európska únia - chorvátčina - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Európska únia - chorvátčina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - karcinom, ne-malih stanica pluća - Антинеопластические i иммуномодулирующие agenti, monoklonsko antitijelo - nivolumab bms je indiciran za liječenje lokalno avanziranog ili metastatskog skvamoznog ne-malih stanica raka pluća (nsclc) nakon prethodne kemoterapije kod odraslih.

Európska únia - chorvátčina - EMA (European Medicines Agency)

janssen-cilag international n.v. - abirateron acetat - prostatske neoplazme - endokrinska terapija - zytiga je navedena s преднизоном ili преднизолоном za liječenje метастатического kastracija otporan raka prostate kod odraslih muškaraca asimptomatska ili slabo simptomi nakon neuspjeha androgen-депривационной terapije kod kojih je kemoterapija nije klinički indicatedthe obrade metastatic кастраци-aksijalni rak prostate kod odraslih muškaraca, čija je bolest napredovala nakon kemoterapije na temelju доцетаксела način.

Európska únia - chorvátčina - EMA (European Medicines Agency)

eli lilly nederland b.v. - necitumumab - karcinom, ne-malih stanica pluća - antineoplastična sredstva - portrazza u kombinaciji s gemcitabinom i cisplatinom kemoterapija je indicirana za liječenje odraslih bolesnika s lokalno uznapredovalim ili metastatskim epidermalnog čimbenika rasta receptora (egfr) izražava pločastih ne-malih stanica raka pluća ne primali kemoterapiju za ovo stanje.

Európska únia - chorvátčina - EMA (European Medicines Agency)

janssen-cilag international n.v.   - bosentan (as monohydrate) - scleroderma, systemic; hypertension, pulmonary - Гипотензивные, - liječenje plućne arterijske hipertenzije (pah) za poboljšanje sposobnosti vježbanja i simptoma u bolesnika s who funkcionalnom klasom iii. efficacy has been shown in: , primary (idiopathic and familial) pah;, pah secondary to scleroderma without significant interstitial pulmonary disease;, pah associated with congenital systemic-to-pulmonary shunts and eisenmenger's physiology. neka poboljšanja su također je prikazano u bolesnika s lag, koji funkcionalna klasa ii. tracleer također je istakao smanjenje broja novih digitalne ulkusa kod pacijenata sa sistemske склеродермией i tijeku bolesti digitalni ulkus .

Európska únia - chorvátčina - EMA (European Medicines Agency)

teva b.v. - leflunomid - arthritis, rheumatoid; arthritis, psoriatic - imunosupresivi - leflunomide indiciran za liječenje odraslih bolesnika s:aktivni reumatoidni artritis kao bolest-mijenjanje противоревматические lijekovi (dmards);aktivni psorijatični artritis. najnovije ili istodobno liječenje гепатотоксичными ili haematotoxic lijekovima (e. metotreksat) može dovesti do povećanog rizika od ozbiljnih nuspojava; stoga treba započeti liječenje leflunomidom pažljivo u vezi s tim aspektima koristi / rizika. osim toga, prebacivanje s лефлуномидом u drugi dmards bez vođenja postupka ispiranja također može povećati rizik od ozbiljnih nuspojava, čak i za dugo nakon komutacije.

Chorvátsko - chorvátčina - HALMED (Agencija za lijekove i medicinske proizvode)

markomed d.o.o. trg braće radića 3 21000 split -

Chorvátsko - chorvátčina - HALMED (Agencija za lijekove i medicinske proizvode)

markomed d.o.o. trg braće radića 3 21000 split -

Chorvátsko - chorvátčina - HALMED (Agencija za lijekove i medicinske proizvode)

sonimed d.o.o. rozganska 8 10110 zagreb -