Европейски съюз - български - EMA (European Medicines Agency)

shionogi b.v. - naldemedine tosilate - запек - Лекарства от запек, периферни опиоидните рецептори - rizmoic е показан за лечение на опиоид-предизвикана от запек (ОИК) при възрастни пациенти, които предварително са обработени слабително.

Европейски съюз - български - EMA (European Medicines Agency)

krka, d.d., novo mesto - atazanavir (as sulfate) - ХИВ инфекции - Антивирусни средства за системно приложение - atazanavir капсули krka, въведени съвместно с ниска доза ritonavir, не е показан за лечение на hiv-1 инфектирани възрастни и педиатрични пациенти на възраст 6 години и по-възрастни в комбинация с други антиретровирусни лекарства. Въз основа На наличните вирус и клинични данни при възрастни пациенти, никаква полза не се очаква при пациенти с щамове, резистентни към множество протеазни инхибитори (≥ 4 мутации ПИ). Избор на atazanavir Крка в лечението на опитни възрастни и деца пациентите трябва да се основава на индивидуална вирусна резистентност и историята на лечението на пациента .

Европейски съюз - български - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - Стомашно-чревни стромални тумори - Други противоракови лекарства, инхибитори на протеинкиназы - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Европейски съюз - български - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - Кистозна фиброза - Други продукти на дихателната система - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

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)

janssen-cilag international nv - rilpivirine - ХИВ инфекции - Антивирусни средства за системно приложение - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.

Европейски съюз - български - EMA (European Medicines Agency)

viiv healthcare b.v. - fostemsavir trometamol - ХИВ инфекции - Антивирусни средства за системно приложение - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - сунитиниб - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - Антинеопластични средства - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Европейски съюз - български - EMA (European Medicines Agency)

gedeon richter plc. - relugolix, norethisterone acetate, estradiol hemihydrate - Лейомиома - Хипофизни и хипоталамични хормони и аналози - ryeqo is indicated in adult women of reproductive age for:- treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Европейски съюз - български - EMA (European Medicines Agency)

koanaa healthcare gmbh - иматиниба мезилат - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - Антинеопластични средства - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. Пациентите, които имат нисък или много нисък риск от рецидив, не трябва да получават помощните терапия. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. С изключение първи път е идентифицирана хронична фаза на ХМЛ, няма контролирани проучвания, които показват клиничен ефект, или увеличава процента на преживяемост при тези заболявания.