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)

accord healthcare s.l.u. - кабазитаксел - Новообразувания На Простатата, Кастраци-Упорит - Антинеопластични средства - treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - абаратер ацетат - Простатни неоплазми - Ендокринна терапия - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - relugolix - Простатни неоплазми - Ендокринна терапия - orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - Захарен диабет тип 2 - Лекарства, използвани при диабет - 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.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - Захарен диабет тип 2 - Лекарства, използвани при диабет - 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 и 5. 1 за наличните данни за различни комбинации).

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - терипаратид - Остеопорозата - Калциева хомеостаза - sondelbay is indicated in adults. Лечение на остеопороза при жени в постменопауза и при мъже с повишен риск от фрактури. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Лечение на остеопороза, свързан с постоянна и системна терапия глюкокортикоидами, при жените и мъжете при повишен риск от фрактури.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - Захарен диабет тип 2 - Лекарства, използвани при диабет - for adult patients with type 2 diabetes mellitus:it is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. it is indicated in combination with a sulphonylurea (i. тройно комбинирано лечение) като допълнение към диета и упражнения при пациенти, недостатъчно контролирани за тяхното максимално переносимой дозата на метформина и сульфонилмочевины. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - Множествена Склероза, Рецидивно-Ремиттирующее - Иммунодепрессанты селективен иммунодепрессанты - 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).