Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - Энтекавир - hepatitis b, kronični - antivirusni lijekovi za sustavnu uporabu - entecavir accord is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. , dekompenziranom bolesti jetre . kao компенсированные i dekompenziranom bolesti jetre, ovaj pokazatelj temelji se na podacima iz kliničkih istraživanja u naivnih pacijenata nukleozida s pozitivnim rezultatom testa na hbeag i hbeag-negativni hbv-infekcije. Što se tiče bolesnika s refluksom hepatitis b lamivudina. Энтекавир accord je također indiciran za liječenje kronične hbv-infekcije u nukleozida naivan pedijatrijska bolesnika od 2 do.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - pramipeksol dihidroklorid monohidrat - parkinson disease; restless legs syndrome - antiparkinsonski lijekovi - pramipeksol accord je indiciran u odraslih za liječenje znakova i simptoma idiopatske parkinsonove bolesti, (bez levodope) ili u kombinaciji s levodopom, ja. tijekom tijeka bolesti, do kasnih faza, kada učinak levodope nestaje ili postaje nedosljedan i dolazi do fluktuacija terapeutskog učinka (kolebljivost na kraju doze ili "on-off"),.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - caspofungin acetat - candidiasis; aspergillosis - antimikotika za sustavnu uporabu - liječenje od invazivnog kandidijaze kod odraslih i pedijatrijska bolesnika. liječenje od invazivnog аспергиллеза kod odraslih i pedijatrijski pacijenti koji резистентны ili netrpeljivosti Амфотерицина u, липидные lijekovi Амфотерицина b i/ili itrakonazol. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. za empirijske terapije namjeravanog gljivične infekcije (npr. candida ili аспергилл) u grozničav, još неоткупоренных za odrasle i pedijatrijska bolesnika.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - deferasirox - iron overload; beta-thalassemia - sve ostale lekovita sredstva, glačalo chelating posrednika - Деферазирокс pristanka indiciran za liječenje kroničnog preko-zasićenih željezom zbog čestih переливаний krvi (≥7 ml/kg/mjesec эритроцитарной mase) u bolesnika s beta-талассемией gradonačelnik u dobi od 6 godina i starije. Деферазирокс accord je također indiciran za liječenje kronične preko-zasićenih željezom zbog трансфузий krvi, kada je terapija дефероксамином kontraindiciran ili неадекватна od sljedećih skupina bolesnika:kod pedijatrijska bolesnika s beta-талассемией s preopterećenje željezom zbog čestih переливаний krvi (≥7 ml/kg/mjesec эритроцитарной mase) u dobi od 2 do 5 godina,kod odraslih i pedijatrijska bolesnika s beta-талассемией s preopterećenje željezom zbog rijetke krvi (.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroksaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitrombotska sredstva - prevencija venske tromboembolije (vte) u odraslih bolesnika koji se podvrgavaju izborni operacije zamjena kuka ili koljena. liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih. (see section 4. 4 for haemodynamically unstable pe patients. liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih. (see section 4. 4 za hemodinamski nestabilne ТЭЛА pacijenata). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 i 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Europska Unija - hrvatski - 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. .

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - dimetil fumarat - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresivi - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).