Europska Unija - hrvatski - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - tumori gastrointestinalnog stroma - drugi antitumorski lijekovi, inhibitori протеинкиназы - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

zentiva pharma d.o.o. - febuksostat - film tableta - 120 mg/1 tableta - jedna film tableta sadrži: 120 mg febuksostata (u obliku febuksostat hemihidrata)

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

zentiva pharma d.o.o. - febuksostat - film tableta - 80 mg/1 tableta - jedna film tableta sadrži: 80 mg febuksostata (u obliku febuksostat hemihidrata)

Europska Unija - hrvatski - EMA (European Medicines Agency)

koanaa healthcare gmbh - иматиниба мезилат - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastična sredstva - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacijenti koji imaju niske ili vrlo nizak rizik od recidiva, ne bi trebali primati adjuvantne terapije. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti.

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

sandoz d.o.o., maksimirska 120, zagreb, hrvatska - pirfenidon - filmom obložena tableta - urbroj: jedna filmom obložena tableta sadrži 267 mg pirfenidona

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

sandoz d.o.o., maksimirska 120, zagreb, hrvatska - pirfenidon - filmom obložena tableta - urbroj: jedna filmom obložena tableta sadrži 801 mg pirfenidona

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

teva gmbh, graf-arco-str. 3, ulm, njemačka - pirfenidon - filmom obložena tableta - urbroj: jedna filmom obložena tableta sadrži 267 mg pirfenidona

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

teva gmbh, graf-arco-str. 3, ulm, njemačka - pirfenidon - filmom obložena tableta - urbroj: svaka filmom obložena tableta sadrži 801 mg pirfenidona

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

zentiva k.s., u kabelovny 130, dolni mecholupy, prag 10, Češka - pirfenidon - filmom obložena tableta - urbroj: jedna filmom obložena tableta sadrži 267 mg pirfenidona

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

zentiva k.s., u kabelovny 130, dolni mecholupy, prag 10, Češka - pirfenidon - filmom obložena tableta - urbroj: jedna filmom obložena tableta sadrži 801 mg pirfenidona