Γερμανία - Γερμανικά - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

accord healthcare b.v. (8182087) - topiramat - filmtablette - teil 1 - filmtablette; topiramat (24994) 100 milligramm

Γερμανία - Γερμανικά - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

accord healthcare b.v. (8182087) - topiramat - filmtablette - teil 1 - filmtablette; topiramat (24994) 25 milligramm

Γερμανία - Γερμανικά - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

accord healthcare b.v. (8182087) - topiramat - filmtablette - topiramat (24994) 50 milligramm

Ευρωπαϊκή Ένωση - Γερμανικά - EMA (European Medicines Agency)

accord healthcare s.l.u. - posaconazol - mykosen - antimykotika zur systemischen anwendung - 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. feuerfestigkeit ist definiert als progression der infektion oder misserfolg zu verbessern, nachdem mindestens 7 tage vor der therapeutischen dosen der wirksamen antimykotischen therapie. posaconazole accord ist ebenfalls indiziert zur prophylaxe von invasiven pilzinfektionen in den folgenden patienten: - patienten empfangen-induktions-chemotherapie bei akuter myeloischer leukämie (aml) oder myelodysplastischen syndromen (mds) voraussichtlich dazu führen, dass verlängerte neutropenie und wer sind hohes risiko für invasive pilzinfektionen;hämatopoetische stammzelltransplantation (hszt) empfänger, die sind im high-dosis der immunsuppressiven therapie der graft-versus-host-krankheit, bei denen ein hohes risiko für invasive pilzinfektionen.

Ευρωπαϊκή Ένωση - Γερμανικά - 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 - antithrombotische mittel - prävention venöser thromboembolien (vte) bei erwachsenen patienten, die sich einer hüft- oder kniegelenksersatzoperation unterziehen. behandlung von tiefen venenthrombosen (tvt) und lungenembolie (pe) und prävention von wiederkehrenden dvt und pe bei erwachsenen. (see section 4. 4 for haemodynamically unstable pe patients. behandlung von tiefen venenthrombosen (tvt) und lungenembolie (pe) und prävention von wiederkehrenden dvt und pe bei erwachsenen. (see section 4. 4 für hämodynamisch instabile pe-patienten). 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. behandlung von tiefen venenthrombosen (tvt) und lungenembolie (pe) und prävention von wiederkehrenden dvt und pe bei erwachsenen. (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 und 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. behandlung von tiefen venenthrombosen (tvt) und lungenembolie (pe) und prävention von wiederkehrenden dvt und pe bei erwachsenen. (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.

Ευρωπαϊκή Ένωση - Γερμανικά - 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).

Ευρωπαϊκή Ένωση - Γερμανικά - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - multiple sklerose, schubförmig-remittierender - immunsuppressiva, selektive immunsuppressiva - 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).

Ευρωπαϊκή Ένωση - Γερμανικά - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Ευρωπαϊκή Ένωση - Γερμανικά - 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).

Ευρωπαϊκή Ένωση - Γερμανικά - EMA (European Medicines Agency)

accord healthcare s.l.u. - tolvaptan - inadäquates adh-syndrom - diuretika, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).