Европейски съюз - български - EMA (European Medicines Agency)

diurnal europe b.v. - хидрокортизон - adrenal hyperplasia, congenital - Кортикостероиди за системна употреба - treatment of congenital adrenal hyperplasia (cah) in adolescents aged 12 years and over and adults.

Европейски съюз - български - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - Хемофилия Б - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Европейски съюз - български - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - амбрисентан - Хипертония, белодробна - Гипотензивные, - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

Европейски съюз - български - EMA (European Medicines Agency)

bayer ag - ривароксабан - arthroplasty, replacement; venous thromboembolism - Антитромботични агенти - xarelto, въведени заедно с ацетилсалицилова киселина (ask) или самостоятелно, или с ask плюс клопидогрел или Тиклопидин, е показан за профилактика на атеротромботических събития при възрастни пациенти след остър коронарен синдром (aux) с повишени нива на кардиальных биомаркери. xarelto, 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. Предотвратяване на венозна тромбоемболия (ВТЕ) при възрастни пациенти, подложени на елективна операция за замяна на тазобедрена или колянна става. Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни. 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. paediatric population treatment 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. paediatric population treatment 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.

Европейски съюз - български - EMA (European Medicines Agency)

mylan ireland limited - ривароксабан - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - Антитромботични агенти - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan 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.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention 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. paediatric population treatment 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. paediatric population treatment 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.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - ривароксабан - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - Антитромботични агенти - Предотвратяване на венозна тромбоемболия (ВТЕ) при възрастни пациенти, подложени на елективна операция за замяна на тазобедрена или колянна става. Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни. (see section 4. 4 for haemodynamically unstable pe patients. Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни. (see section 4. 4 за гемодинамически нестабилна ТЭЛА пациенти). 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. Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни. (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 и 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. Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни. (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.

Европейски съюз - български - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - eptacog beta (activated) - hemophilia a; hemophilia b - Антихеморагични - cevenfacta is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with high-responding inhibitors to coagulation factors viii or ix (i. ≥5 bethesda units (bu)); in patients with congenital haemophilia with low titre inhibitors (bu.

Европейски съюз - български - EMA (European Medicines Agency)

gedeon richter plc. - фолитропин алфа - Ановулация - Полови хормони и слиза на половата система, - in adult women:anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift);follitropin alfa in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. В клинични проучвания при тези пациенти са били идентифицирани ендогенен нивото на серумните нива на lh < 1. 2 iu / l. in adult men:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy.

Европейски съюз - български - EMA (European Medicines Agency)

takeda manufacturing austria ag - човешки протеин С - purpura fulminans; protein c deficiency - Антитромботични агенти - ceprotin is indicated for prophylaxis and treatment of  purpura fulminans  coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein c deficiency.

Европейски съюз - български - EMA (European Medicines Agency)

instituto grifols s.a. - Имуноглобулин нормален човек - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - Имунни серуми и имуноглобулини - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.