Euroopan unioni - bulgaria - EMA (European Medicines Agency)

leo pharma a/s - tralokinumab - Дерматит, Атопич - Други дерматологични препарати - adtralza is indicated for the treatment of moderate to severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.

Euroopan unioni - bulgaria - 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.

Euroopan unioni - bulgaria - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - Захарен диабет тип 2 - Лекарства, използвани при диабет - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan 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. sitagliptin/metformin hydrochloride mylan 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. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan 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.

Euroopan unioni - bulgaria - EMA (European Medicines Agency)

novartis europharm limited - руксолитиниб (като фосфат) - myeloproliferative disorders; polycythemia vera; graft vs host disease - Антинеопластични средства - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Полицитемия Вера (px)jakavi е показан за лечение на възрастни пациенти с полицитемия вера, които са резистентни или с непоносимост към гидроксимочевины. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Euroopan unioni - bulgaria - EMA (European Medicines Agency)

advanced accelerator applications - l-arginine hydrochloride, l-lysine hydrochloride - Лъчева Щети - detoxifying agents for antineoplastic treatment - lysakare е показан за намаляване на излагането на радиация при бъбречна пептид-рецепторного радионуклидной терапия (prrt) с Лютеций (177lu) oxodotreotide при възрастни.

Euroopan unioni - bulgaria - EMA (European Medicines Agency)

dechra regulatory b.v. - миртазапин - psychoanaleptics, antidepressants in combination with psycholeptics - Котки - За увеличаване на теглото на тялото при котките, имат лош апетит и загуба на тегло в резултат на хронични заболявания.

Euroopan unioni - bulgaria - EMA (European Medicines Agency)

axunio pharma gmbh - pirfenidone - Идиопатична белодробна фиброза - Имуносупресори - pirfenidone aet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Euroopan unioni - bulgaria - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - elotuzumab - Множествена миелома - Антинеопластични средства - empliciti е посочено в комбинация с леналидомидом и дексаметазоном за лечение на множествена миеломы при възрастни пациенти, които са получили най-малко един курс на терапия (виж раздели 4. 2 и 5.

Euroopan unioni - bulgaria - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cobicistat, atazanavir - ХИВ инфекции - Антивирусни средства за системно приложение - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4. 4 и 5.

Euroopan unioni - bulgaria - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - Деферипрон - beta-thalassemia; iron overload - Всички други терапевтични продукти - ferriprox монотерапия е показан за лечение на желязо при пациенти с таласемия големи, когато текущата chelation терапия е противопоказано или неадекватна. ferriprox в комбинация с друга хелатор е показан при пациенти с талассемией майор, когато монотерапия с всеки хелатор на желязото неефективни, или за профилактика или лечение на животозастрашаващи последици от претоварване с желязо (главно сърдечна претоварване) оправдава бързо или интензивно корекция.