Evrópusambandið - króatíska - 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.

Bosnía og Hersegóvína - króatíska - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

evropa lijek pharma d.o.o. - ропинирол - tableta s produženim oslobađanjem - 2 mg/1 tableta - 1 tableta sa produženim oslobađanjem sadrži: 2 mg ropinirola (u obliku ropinirolhidrohlorida)

Bosnía og Hersegóvína - króatíska - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

evropa lijek pharma d.o.o. - ропинирол - tableta sa produženim oslobađanjem - 4 mg/1 tableta - 1 tableta sa produženim oslobađanjem sadrži: 4 mg ropinirola (u obliku ropinirolhidrohlorida)

Bosnía og Hersegóvína - króatíska - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

evropa lijek pharma d.o.o. - ропинирол - tableta sa produženim oslobađanjem - 8 mg/1 tableta - 1 tableta sa produženim oslobađanjem sadrži: 8 mg ropinirola (u obliku ropinirolhidrohlorida)

Svartfjallaland - króatíska - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

druŠtvo za trgovinu na veliko farmaceutskim proizvodima "glosarij" d.o.o.-podgorica - abrocitinib - film tableta - 50mg

Svartfjallaland - króatíska - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

druŠtvo za trgovinu na veliko farmaceutskim proizvodima "glosarij" d.o.o.-podgorica - abrocitinib - film tableta - 100mg

Svartfjallaland - króatíska - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

druŠtvo za trgovinu na veliko farmaceutskim proizvodima "glosarij" d.o.o.-podgorica - abrocitinib - film tableta - 200mg

Svartfjallaland - króatíska - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

"glk pharma" druŠtvo sa ograniČenom odgovornoŠĆu, podgorica - rosuvastatin, ezetimib - film tableta - 10mg + 10mg

Svartfjallaland - króatíska - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

"glk pharma" druŠtvo sa ograniČenom odgovornoŠĆu, podgorica - rosuvastatin, ezetimib - film tableta - 20mg + 10mg

Bosnía og Hersegóvína - króatíska - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

bosnalijek d.d. - Периндоприл - tableta - 2 mg/1 tableta - 1 tableta sadrži: 2 mg perindopril tertbutilamina