Österrike - tyska - AGES (Agentur für Gesundheit und Ernährungssicherheit)

accord healthcare b.v. - atorvastatin calcium trihydrat -

Österrike - tyska - AGES (Agentur für Gesundheit und Ernährungssicherheit)

accord healthcare b.v. - atorvastatin calcium trihydrat -

Österrike - tyska - AGES (Agentur für Gesundheit und Ernährungssicherheit)

accord healthcare b.v. - atorvastatin calcium trihydrat -

Österrike - tyska - AGES (Agentur für Gesundheit und Ernährungssicherheit)

accord healthcare b.v. - atorvastatin calcium trihydrat -

Tyskland - tyska - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

accord healthcare b.v. (8182087) - mepivacainhydrochlorid - injektionslösung - teil 1 - injektionslösung; mepivacainhydrochlorid (05638) 20 milligramm

Tyskland - tyska - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

accord healthcare b.v. (8182087) - mepivacainhydrochlorid - injektionslösung - teil 1 - injektionslösung; mepivacainhydrochlorid (05638) 10 milligramm

Europeiska unionen - tyska - 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).

Europeiska unionen - tyska - 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.

Europeiska unionen - tyska - 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.

Europeiska unionen - tyska - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, typ 2 - drogen bei diabetes verwendet - 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.