Европейски съюз - български - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - Арсеник Триоксид - Левкемия, промиелоцитна, остра - Антинеопластични средства - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene. Скоростта на реакция друг остър миелобластный подтипове на левкемия до триоксида арсен не е считан за.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - Апиксабан - venous thromboembolism; stroke; arthroplasty - Антитромботични агенти - prevention of venous thromboembolic events (vte) in adult patients who have undergone elective hip or knee replacement surgery. Профилактика на инсулт и системна емболия при възрастни пациенти с неклапанной фибрилляцией мъждене (nvaf), с един или повече рискови фактори, като например инсулт или транзиторная исхемична атака (ТИА); възраст ≥ 75 години; хипертония; диабет; симптоматична сърдечна недостатъчност (nyha клас ≥ втора). Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни (виж раздел 4. 4 за гемодинамически нестабилна ТЭЛА пациенти). prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (nvaf), with one or more risk factors, such as prior stroke or transient ischaemic attack (tia); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (nyha class ≥ ii). Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни (виж раздел 4. 4 за гемодинамически нестабилна ТЭЛА пациенти).

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)

roche registration gmbh - pertuzumab, trastuzumab - Неоплазми на гърдата - Антинеопластични средства - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Европейски съюз - български - EMA (European Medicines Agency)

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - Липидни модифициращи агенти - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Европейски съюз - български - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - Имуносупресори - multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) е показан за лечение на възрастни пациенти с по-рано нелекувана множествена миеломой, на които не се разчита за трансплантация. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 и 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) е показан за лечение на възрастни пациенти с по-рано нелекувана множествена миеломой, на които не се разчита за трансплантация. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 и 5. follicular lymphomalenalidomide krka 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)

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - Имуносупресори - multiple myelomalenalidomide krka d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) е показан за лечение на възрастни пациенти с по-рано нелекувана множествена миеломой, на които не се разчита за трансплантация. lenalidomide krka d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. 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)

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)

boehringer ingelheim vetmedica gmbh - eprinomectin, esafoxolaner, praziquantel - eprinomectin, combinations, , avermectins, antiparasitic products, insecticides and repellents - Котки - for cats with, or at risk from mixed infections by cestodes, nematodes and ectoparasites. Ветеринарен officinalis лекарство е единствено показва, когато всичките три групи са насочени в същото време.

Европейски съюз - български - EMA (European Medicines Agency)

amarin pharmaceuticals ireland limited - icosapent ethyl - Дислипидемиите - Липидни модифициращи агенти - indicated to reduce cardiovascular risk as an adjunct to statin therapy.