Европейски съюз - български - EMA (European Medicines Agency)

mylan ireland limited - леналидомид - Множествена миелома - Имуносупресори - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Европейски съюз - български - 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.

Европейски съюз - български - EMA (European Medicines Agency)

mylan ireland limited - азацитидин - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - Антинеопластични средства - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Европейски съюз - български - EMA (European Medicines Agency)

mylan ireland limited - Арсеник Триоксид - Левкемия, промиелоцитна, остра - Антинеопластични средства - Триоксид арсен mylan в е показан за индукция на ремисия и консолидация при възрастни пациенти с за първи път разкри нисък до среден риск от остра промиелоцитарной левкемия (ОПЛ) (левкоцити ≤ 10 х 103/МЛ) в комбинация с транс-ретиноевая киселина (ПРОТИВОТАНКОВИ)- пристъпно/продължителна остра промиелоцитарной левкемия (ОПЛ) (предишна обращение трябва да съдържа ретиноиди и химиотерапия)се характеризира с наличието на t(15;17) транслокации и/или наличието на промиелоцитарный левкемия/ретиноевая киселина рецептор Алфа (ПМЛ/rar Алфа) ген. Скоростта на реакция друг остър миелобластный подтипове на левкемия до триоксида арсен не beenexamined.

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)

mylan ireland limited - абаратер ацетат - Простатни неоплазми - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan 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 indicated. the 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)

mylan ireland limited - диметил фумарат - Множествена Склероза, Рецидивно-Ремиттирующее - Имуносупресори - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Европейски съюз - български - EMA (European Medicines Agency)

mylan pharmaceuticals limited - деферазирокс - iron overload; beta-thalassemia - Хелати желязо - Деферазирокс mylan в е показан за лечение на хронично претоварване с желязо поради честите преливания на кръв (≥7 ml/kg/месец эритроцитарной маса) при пациенти с бета-талассемией майор на 6-годишна възраст и olderthe лечение на хронична умора от информацията на желязо поради трансфузий кръв, когато терапия дефероксамином противопоказан или неадекватна при следните групи пациенти:при педиатрични пациенти с бета-талассемией с претоварване с желязо поради честите преливания на кръв (≥7 ml/kg/месец эритроцитарной маса) на възраст от 2 до 5 години в педиатрични и възрастни пациенти с бета-талассемией с претоварване с желязо поради сцени преливане на кръв (.

Европейски съюз - български - EMA (European Medicines Agency)

mylan ireland limited - финголимод хидрохлорид - Множествена Склероза, Рецидивно-Ремиттирующее - Имуносупресори - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 и 5. 1)orpatients с бързо се развива тежка relapsing начин множествена склероза се определя от 2 или по-тежки рецидиви в рамките на една година, и с 1 или по-гадолиний активизиране на огнища на ядрено-магнитен резонанс на главния мозък или значително увеличаване на натоварването Т2 лезии в сравнение с най-новите ядрено-магнитен резонанс.

Европейски съюз - български - EMA (European Medicines Agency)

mylan ireland limited - финголимод хидрохлорид - Множествена Склероза, Рецидивно-Ремиттирующее - Имуносупресори - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 и 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.