Unione Europea - olandese - EMA (European Medicines Agency)

accord healthcare s.l.u. - eptifibatide - myocardinfarct - antitrombotische middelen - eptifibatide accord is bedoeld voor gebruik met acetylsalicylzuur en ongefractioneerde heparine. eptifibatide overeenstemming is geïndiceerd voor de preventie van vroegtijdig myocardinfarct bij volwassenen presenteren met instabiele angina pectoris of een non-q-wave myocardinfarct, met de laatste episode van pijn op de borst die binnen 24 uur en met een elektrocardiogram (ecg) wijzigingen en/of verhoogde cardiale enzymen. patiënten de meeste kans om te profiteren van eptifibatide overeenstemming behandeling zijn die een hoog risico van het ontwikkelen van een myocardinfarct in de eerste 3-4 dagen na het begin van de acute angina pectoris symptomen, waaronder bijvoorbeeld de landen die waarschijnlijk vroegtijdig ptca (percutane transluminale coronaire angioplastiek).

Unione Europea - olandese - 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. behalve in nieuw gediagnosticeerde cml in de chronische fase, er zijn geen gecontroleerde studies tonen een klinisch voordeel of een toegenomen overleving voor deze ziekten. .

Unione Europea - olandese - EMA (European Medicines Agency)

accord healthcare s.l.u. - pramipexol dihydrochloride monohydraat - parkinson disease; restless legs syndrome - geneesmiddelen tegen parkinson - pramipexol accord is geïndiceerd voor de behandeling van de tekens en symptomen van de idiopathische ziekte van parkinson, alleen (zonder levodopa) of in combinatie met levodopa, i. in de loop van de ziekte, tot de late stadia wanneer het effect van levodopa afneemt of inconsistent wordt en fluctuaties van het therapeutisch effect optreden (eind-van-dosis of 'aan-uit'-fluctuaties).

Unione Europea - olandese - EMA (European Medicines Agency)

accord healthcare s.l.u. - entecavir - hepatitis b, chronisch - antivirale middelen voor systemisch gebruik - 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. , gedecompenseerde leverziekte. voor zowel gecompenseerd en gedecompenseerde leverziekte, deze indicatie is gebaseerd op klinische gegevens in nucleoside-naïeve patiënten met hbeag-positieve en hbeag-negatieve hbv-infectie. met betrekking tot patiënten met lamivudine-refractaire hepatitis b. entecavir akkoord is ook geïndiceerd voor de behandeling van chronische hbv-infectie in nucleoside-naïeve pediatrische patiënten van 2 tot.

Unione Europea - olandese - EMA (European Medicines Agency)

accord healthcare s.l.u. - lacosamide - epilepsie - van anti-epileptica, - 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.

Unione Europea - olandese - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomide - multiple myeloma - immunosuppressiva - 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) is geïndiceerd voor de behandeling van volwassen patiënten met eerder behandelde multipel myeloom die niet in aanmerking komen voor transplantatie. lenalidomide akkoord in combinatie met dexamethason is geïndiceerd voor de behandeling van multipel myeloom bij volwassen patiënten die minstens één eerdere 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).

Unione Europea - olandese - EMA (European Medicines Agency)

accord healthcare s.l.u. - posaconazol - mycobacteriologie - antimycotica voor systemisch gebruik - 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. ongevoeligheid is gedefinieerd als de progressie van infectie of niet verbeteren na een minimum van 7 dagen voorafgaande therapeutische doses van de effectieve antifungale therapie. posaconazole akkoord is ook geïndiceerd voor de profylaxe van invasieve schimmelinfecties bij de volgende patiënten: patiënten die een remissie-inductie chemotherapie voor acute myeloïde leukemie (aml) of myelodysplastische syndromen (mds) zal naar verwachting resulteren in langdurige neutropenie en die een hoog risico van het ontwikkelen van invasieve schimmelinfecties;hematopoëtische stamceltransplantatie (hsct) ontvangers die het ondergaan van een hoge dosis immunosuppressieve therapie voor graft-versus-host ziekte en die een hoog risico van het ontwikkelen van invasieve schimmelinfecties.

Unione Europea - olandese - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitrombotische middelen - preventie van veneuze trombo-embolie (vte) bij volwassen patiënten die een electieve heup- of knievervangende operatie ondergaan. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (see section 4. 4 for haemodynamically unstable pe patients. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (see section 4. 4 voor haemodynamically instabiel pe-patiënten). 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. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (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 en 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. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (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.

Unione Europea - olandese - EMA (European Medicines Agency)

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

Unione Europea - olandese - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioedemas, erfelijk - 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.