Kroatien - Kroatisch - HALMED (Agencija za lijekove i medicinske proizvode)

zentiva k.s., u kabelovny 130, dolni mecholupy, prag 10, Češka - сунитиниб - kapsula, tvrda - 25 mg - urbroj: jedna kapsula sadrži 25 mg sunitiniba

Kroatien - Kroatisch - HALMED (Agencija za lijekove i medicinske proizvode)

zentiva k.s., u kabelovny 130, dolni mecholupy, prag 10, Češka - сунитиниб - kapsula, tvrda - 50 mg - urbroj: jedna kapsula sadrži 50 mg sunitiniba

Kroatien - Kroatisch - HALMED (Agencija za lijekove i medicinske proizvode)

krka d.d., novo mesto, Šmarješka cesta 6, novo mesto, slovenija - natrijev deksametazonfosfat - otopina za injekciju / infuziju - 4 mg/ml - urbroj: jedna ampula od 1 ml sadrži 4 mg deksametazonfosfata (u obliku natrijevog deksametazonfosfata)

Kroatien - Kroatisch - HALMED (Agencija za lijekove i medicinske proizvode)

krka d.d., novo mesto, Šmarješka cesta 6, novo mesto, slovenija - natrijev deksametazonfosfat - otopina za injekciju / infuziju - 8 mg/2 ml - urbroj: jedna ampula od 2 ml sadrži 8 mg deksametazonfosfata (u obliku natrijevog deksametazonfosfata)

Kroatien - Kroatisch - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - deksametazon - tableta - urbroj: svaka tableta sadrži 4 mg deksametazona

Kroatien - Kroatisch - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - deksametazon - tableta - urbroj: svaka tableta sadrži 8 mg deksametazona

Kroatien - Kroatisch - HALMED (Agencija za lijekove i medicinske proizvode)

zentiva k.s., u kabelovny 130, dolni mecholupy, prag 10, Češka - deksametazon - tableta - urbroj: svaka tableta sadrži 4 mg deksametazona

Europäische Union - Kroatisch - 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.

Europäische Union - Kroatisch - 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.

Europäische Union - Kroatisch - EMA (European Medicines Agency)

pfizer europe ma eeig - inotuzumab ozogamicin - prekursorska stanica limfoblastične leukemije-limfom - antineoplastična sredstva - besponsa je indicirana kao monoterapija za liječenje odraslih osoba s recidiviranom ili refraktornom cd22 pozitivnom akutnom limfoblastičnom leukemijom b stanica (all). odrasli bolesnici s philadelphia kromosomom pozitivnim (ph +) relapsiranim ili vatrostalnim b stanicama prekursora all trebali bi imati neuspješan tretman s najmanje 1 inhibitorom tirozin kinaze (tki).