Unia Europejska - chorwacki - EMA (European Medicines Agency)

teva b.v. - reslizumab - astma - drugi sistemski lijekovi za opstruktivne plućne bolesti dišnih putova, - cinqaero je indiciran kao dodatna terapija u odraslih bolesnika s teškom astmom eozinofilni glikemija unatoč visokom dozom udahnuti kortikosteroidi plus još jedan lijek za terapiju održavanja.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

astrazeneca ab - roflumilast - plućna bolest, kronična opstruktivna - lijekovi za opstruktivne plućne bolesti dišnih putova, - daliresp je indiciran za terapiju održavanja teške kronične opstruktivne plućne bolesti (kopb) (fev1 manji od 50% predvidjeti) povezane s kroničnim bronhitisom kod odraslih bolesnika s učestalim egzacerbacijama kao dodatak bronhodilatatorima.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multipli mijelom - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. u kombinaciji s бортезомибом, талидомидом i дексаметазоном za liječenje odraslih bolesnika s prvi put utvrđenom multiplog mijeloma, koji imaju pravo za obavljanje autologna transplantacija matičnih stanica . u kombinaciji s леналидомидом i дексаметазоном i бортезомибом i дексаметазоном za liječenje odraslih bolesnika s multiplog mijeloma, koji je dobio barem jedne prethodne terapije. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. u monoterapiji za liječenje odraslih bolesnika s ponavljajućom i uporan multiplog mijeloma, čija je ranije terapija je uključivala inhibitor протеасом i иммуномодулирующего agent i koji je pokazao napredovanje bolesti na zadnje terapije. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

astrazeneca ab - roflumilast - plućna bolest, kronična opstruktivna - lijekovi za opstruktivne plućne bolesti dišnih putova, - daxas je indiciran za terapiju održavanja teške kronične opstruktivne plućne bolesti (kopb) (fev1 manji od 50% predvidjeti) povezane s kroničnim bronhitisom kod odraslih bolesnika s učestalim egzacerbacijama u anamnezi kao dodatak bronhodilatacijska terapija.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

covis pharma europe b.v. - aclidinium bromid, формотерола фумарата dihidrat - plućna bolest, kronična opstruktivna - lijekovi za opstruktivne plućne bolesti dišnih putova, - duaklir genuair je označen kao liječenje bronhodilatatora za održavanje radi ublažavanja simptoma kod odraslih osoba s kroničnom opstruktivnom plućnom bolesti (copd).

Unia Europejska - chorwacki - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - lijekovi za opstruktivne plućne bolesti dišnih putova, - asthma duoresp spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β₂ adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β₂ adrenoceptor agonists. orin patients already adequately controlled on both inhaled corticosteroids and long-acting β₂ adrenoceptor agonists. copdduoresp spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev₁).

Unia Europejska - chorwacki - EMA (European Medicines Agency)

covis pharma europe b.v. - aclidinium bromide - plućna bolest, kronična opstruktivna - lijekovi za opstruktivne plućne bolesti dišnih putova, - farmakovigilancije genuair je indiciran kao bronhodilatacijska terapija održavanja za ublažavanje simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (kopb).

Unia Europejska - chorwacki - EMA (European Medicines Agency)

novartis europharm ltd - bromid glycopyrronium - plućna bolest, kronična opstruktivna - lijekovi za opstruktivne plućne bolesti dišnih putova, - enurev breezhaler je označen kao liječenje bronhodilatatora za održavanje radi ublažavanja simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (copd).

Unia Europejska - chorwacki - EMA (European Medicines Agency)

novartis europharm limited - indakaterol maleat - plućna bolest, kronična opstruktivna - lijekovi za opstruktivne plućne bolesti dišnih putova, - hirobriz breezhaler je indiciran za liječenje bronhodilatatora kod opstrukcije protoka zraka kod odraslih osoba s kroničnom opstruktivnom plućnom bolesti.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult 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. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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 dfsp. 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. .