Europäische Union - Deutsch - EMA (European Medicines Agency)

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

Europäische Union - Deutsch - EMA (European Medicines Agency)

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

Europäische Union - Deutsch - EMA (European Medicines Agency)

accord healthcare s.l.u. - abirateronacetat - prostata-neoplasmen - endokrine therapie - 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.

Europäische Union - Deutsch - EMA (European Medicines Agency)

accord healthcare s.l.u. - capecitabin - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastische mittel - capecitabin accord ist angezeigt für die adjuvante behandlung von patienten nach der operation von stadium-iii (dukes 'stadium-c) kolonkarzinom. capecitabin accord ist indiziert für die behandlung von metastasierendem dickdarmkrebs. capecitabin accord ist angezeigt zur first-line-behandlung von fortgeschrittenem magenkrebs in kombination mit einer platin-basierten chemotherapie. capecitabin accord ist in kombination mit docetaxel ist indiziert für die behandlung von patienten mit lokal fortgeschrittenem oder metastasiertem brustkrebs nach versagen der zytotoxischen chemotherapie. vorherige therapie sollte ein anthracyclin enthalten. capecitabin accord ist auch indiziert als monotherapie für die behandlung von patienten mit lokal fortgeschrittenem oder metastasiertem brustkrebs nach versagen der taxane und einer anthrazyklin-haltigen chemotherapie nicht angesprochen haben oder für die weitere anthrazyklin-therapie nicht indiziert ist.

Europäische Union - Deutsch - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomid - multiples myelom - immunsuppressiva - 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) ist indiziert für die behandlung erwachsener patienten mit zuvor unbehandeltem multiplen myelom, die nicht die voraussetzungen für eine transplantation. lenalidomid accord in kombination mit dexamethason ist indiziert für die behandlung des multiplen myeloms bei erwachsenen patienten, die erhalten haben, mindestens eine vorherige therapie. 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).

Europäische Union - Deutsch - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastische mittel - 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.

Europäische Union - Deutsch - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetes mellitus, typ 2 - drogen bei diabetes verwendet - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 und 5. 1 für verfügbare daten zu verschiedenen kombinationen).

Europäische Union - Deutsch - EMA (European Medicines Agency)

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

Europäische Union - Deutsch - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - prostata-neoplasmen - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Europäische Union - Deutsch - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastische mittel - azacitidine accord ist indiziert für die behandlung von erwachsenen patienten, die nicht förderfähig sind für die hämatopoetische stammzelltransplantation (hszt) mit:- intermediate-2 und high-risk myelodysplastischen syndromen (mds) nach dem international prognostic scoring system (ipss),- chronische myelomonocytic leukämie (cmml) mit 10-29 % knochenmark blasten ohne myeloproliferative störung,- akute myeloische leukämie (aml) mit 20-30 % blasten und multi-lineage dysplasie, nach angaben der world health organisation (who) - klassifikation,- aml mit >30% knochenmark blasten nach der who-klassifikation.