Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - cinakalcet-hidroklorid - hyperparathyreosis - kalcium homeosztázis - másodlagos hyperparathyroidismadultstreatment a szekunder hyperparathyreosis (hpt) szenvedő felnőtt betegek a végstádiumú vesebetegség (drt) a fenntartó a dialízis kezelés. gyermekgyógyászati populationtreatment a szekunder hyperparathyreosis (hpt) a gyermekek 3 éves vagy idősebb a végstádiumú vesebetegség (drt) a fenntartó a dialízis kezelés, akinek másodlagos hpt nem megfelelően ellenőrzött a standard ellátás, kezelés (lásd 4. a cinakalcet accordpharma lehet használni, mint egy része a terápiás kezelés, beleértve a foszfát kötőanyagok és/vagy d-vitamin szterolok, mint megfelelő (lásd 5. mellékpajzsmirigy-carcinoma, primer hyperparathyreosis a adultsreduction a hypercalcaemia a felnőtt betegek:mellékpajzsmirigy-carcinoma. a primer hyperparathyreosis, akinek parathyroidectomy lenne feltüntetett alapján a szérum kalcium szintje (meghatározott vonatkozó kezelési irányelvek), de akiben parathyroidectomy klinikailag nem megfelelő, illetve ellenjavallt.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - daganatellenes szerek - 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.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - daganatellenes szerek - 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.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomide - myeloma multiplex - immunszuppresszánsok - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) kezelésére javallt felnőtt betegek korábban nem kezelt, myeloma multiplex, akik nem jogosultak transzplantációs. lenalidomid accord dexametazonnal kezelésére javallt, a myeloma-ban szenvedő felnőtt betegek aki kapott már legalább egy előzetes kezelés. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - szunitinibbel - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - daganatellenes szerek - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioödéma, örökletes - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, 2. típus - cukorbetegségben szedett gyógyszerek - 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.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - a sclerosis multiplex, a relapszáló-remittáló - immunszuppresszánsok, szelektív immunszuppresszánsok - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidinnel - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - daganatellenes szerek - azacitidin accord kezelésére javallt, a felnőtt betegeknél, akik nem jogosultak haemopoetikus őssejt-transzplantáció (hsct) a:- köztes-2 magas kockázatú mielodiszpláziás szindrómában (mds) szerint a nemzetközi prognosztikai pontozási rendszer (ipss),- krónikus myelomonocytic leukémia (cmml) a 10-29 % csontvelő blast nélkül myeloproliferative zavar,- akut myeloid leukémia (aml) 20-30 % blast, valamint a multi-lineage dysplasia szerint az egészségügyi világszervezet (who) osztályozás,- aml a >30% csontvelő blast szerint a who osztályozás.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - abirateron-acetát - prosztatikus daganatok - endokrin terápia - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.