Norge - norsk - Statens legemiddelverk

accord healthcare b.v. - naltreksonhydroklorid - tablett, filmdrasjert - 50 mg

Norge - norsk - Statens legemiddelverk

accord healthcare b.v. - vinorelbintartrat - konsentrat til infusjonsvæske, oppløsning - 10 mg/ ml

Den europeiske union - norsk - EMA (European Medicines Agency)

accord healthcare s.l.u. - posakonazol - mycoses - antimykotika for systemisk bruk - 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. refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. posaconazole accord er også indisert for profylakse av invasive soppinfeksjoner i følgende pasienter: pasienter som mottar syndenes-induksjon kjemoterapi for akutt myelogen leukemi (aml) eller myelodysplastic syndromer (mds) forventes å resultere i langvarig neutropenia og som har høy risiko for å utvikle invasive soppinfeksjoner;blodkreft stamcelletransplantasjon (hsct) mottakere som er under høy-dose immunsuppressiv terapi for graft versus host disease og som har høy risiko for å utvikle invasive soppinfeksjoner.

Norge - norsk - Statens legemiddelverk

accord healthcare b.v. - solifenacinsuksinat - tablett, filmdrasjert - 5 mg

Norge - norsk - Statens legemiddelverk

accord healthcare b.v. - solifenacinsuksinat - tablett, filmdrasjert - 10 mg

Den europeiske union - norsk - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroksaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antithrombotic agents - forebygging av venøs tromboembolisme (vte) hos voksne pasienter som gjennomgår valgfri hofte- eller kneutskifting. behandling av dyp venetrombose (dvt) og lungeemboli (pe), og forebygging av tilbakevendende dvt og pe i voksne. (see section 4. 4 for haemodynamically unstable pe patients. behandling av dyp venetrombose (dvt) og lungeemboli (pe), og forebygging av tilbakevendende dvt og pe i voksne. (see section 4. 4 for haemodynamically ustabil pe pasienter). 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. behandling av dyp venetrombose (dvt) og lungeemboli (pe), og forebygging av tilbakevendende dvt og pe i voksne. (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 og 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. behandling av dyp venetrombose (dvt) og lungeemboli (pe), og forebygging av tilbakevendende dvt og pe i voksne. (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.

Norge - norsk - Statens legemiddelverk

accord healthcare b.v. - aciklovirnatrium - konsentrat til infusjonsvæske, oppløsning - 25 mg/ ml

Norge - norsk - Statens legemiddelverk

accord healthcare b.v. - atosibanacetat - injeksjonsvæske, oppløsning i ferdigfylt sprøyte - 6.75 mg/0.9 ml

Den europeiske union - norsk - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - multippel sklerose, relapsing-remitting - immunosuppressants, selektiv immunosuppressants - 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).

Den europeiske union - norsk - 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.