欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - abiraterone acetate - prostatic neoplasms - endocrine therapy - 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.

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - eptifibatide - myocardial infarction - antithrombotic agents - eptifibatide accord is intended for use with acetylsalicylic acid and unfractionated heparin.eptifibatide accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ecg) changes and/or elevated cardiac enzymes.patients most likely to benefit from eptifibatide accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early ptca (percutaneous transluminal coronary angioplasty).

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - voriconazole - aspergillosis; candidiasis; mycoses - antimycotics for systemic use, triazole derivatives - voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows:treatment of invasive aspergillosis;treatment of candidaemia in non-neutropenic patients;treatment of fluconazole-resistant serious invasive candida infections (including c. krusei);treatment of serious fungal infections caused by scedosporium spp. and fusarium spp.voriconazole accord should be administered primarily to patients with progressive, possibly life-threatening infections.

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - memantine hydrochloride - alzheimer disease - other anti-dementia drugs - treatment of patients with moderate to severe alzheimer’s disease.

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - pregabalin - anxiety disorders; epilepsy - antiepileptics, - epilepsypregabalin accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.generalised anxiety disorderpregabalin accord is indicated for the treatment of generalised anxiety disorder (gad) in adults.

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - lacosamide - epilepsy - antiepileptics, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.•         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - posaconazole - mycoses - antimycotics for systemic use - posaconazole accord is indicated for use in the treatment of the following fungal infections in adults:invasive aspergillosis;fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.posaconazole accord is also indicated for prophylaxis of invasive fungal infections in the following patients: patients receiving remission-induction chemotherapy for acute myelogenous leukemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - azacitidine accord is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:- intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),- chronic myelomonocytic leukaemia (cmml) with 10-29 % marrow blasts without myeloproliferative disorder,- acute myeloid leukaemia (aml) with 20-30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification,- aml with >30% marrow blasts according to the who classification.

欧州連合 - 英語 - EMA (European Medicines Agency)

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

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - deferasirox - iron overload; beta-thalassemia - all other therapeutic products, iron chelating agents - deferasirox accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.deferasirox accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (