Европейски съюз - български - EMA (European Medicines Agency)

eli lilly nederland b.v. - abemaciclib - Неоплазми на гърдата - Антинеопластични средства - early breast cancerverzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence (see section 5. in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist. advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

Европейски съюз - български - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - Аутологичная Сd34+ клетки е обогатен популация, която съдържа хемопоетични стволови клетки, трансформирани с lentiglobin bb305 лентивирусные вектори, кодирующие бета-а-t87q-глобина гени - бета-таласемия - other hematological agents - zynteglo е показан за лечение на пациенти на възраст над 12 години с трансфузионно-зависими β таласемия (ТДТ), които не са β0/β0 генотип, за които трансплантация на хемопоетични стволови клетки (gsk) трансплантацията е подходящо, както за човешкото лейкоцитарного антиген (hla) съответства на коментари донори gsk не е наличен.

Европейски съюз - български - EMA (European Medicines Agency)

astrazeneca ab - chadox1-sars-cov-2 - covid-19 virus infection - Ваксини - vaxzevria is indicated for active immunisation to prevent covid 19 caused by sars cov 2, in individuals 18 years of age and older. Използването на тази ваксина трябва да бъде приложена в съответствие с официалните препоръки.

Европейски съюз - български - EMA (European Medicines Agency)

takeda manufacturing austria ag - човешки протеин С - purpura fulminans; protein c deficiency - Антитромботични агенти - ceprotin is indicated for prophylaxis and treatment of  purpura fulminans  coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein c deficiency.

Европейски съюз - български - EMA (European Medicines Agency)

cangene europe limited - човешки имуноглобулин срещу хепатит В. - immunization, passive; hepatitis b - Специфични имуноглобулини - Иммунопрофилактика хепатит В - В случай на случайно попадане на не ваксинирани участници (включително и лица, ваксинации, които isincomplete статус или неизвестен). - В haemodialysed пациенти, докато ваксината не влезе в сила. - При новородено на вируса на хепатит В носител-майка. - По теми, които не показват имунен отговор (не е измерено хепатит b антитела след ваксинацията и през които в непрекъснат профилактика е необходимо във връзка с непрекъснат риск от заразяване с хепатит В. Трябва да се вземат предвид също и други официални препоръки за правилното използване на човека хепатит b имуноглобулин за внутримышечного употреба.

Европейски съюз - български - EMA (European Medicines Agency)

cytonet gmbh kg - Човешките клетки гетерологичных на черния дроб - Нарушения на цикъла на уреята, вродено - Други стомашно-чревния тракт и обмяната на веществата средства, - Лечение на прекъсване на цикъла на урея (ucd), който.

Европейски съюз - български - EMA (European Medicines Agency)

merck sharp & dohme b.v. - Пембролизумаб - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - Антинеопластични средства - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. Пациенти с egfr или АЛК положителни тумори мутации също трябва да получават таргетную терапия до получаване на Кейтруда. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Европейски съюз - български - EMA (European Medicines Agency)

bayer ag - finerenone - renal insufficiency, chronic; diabetes mellitus, type 2 - Агенти, действащи върху системата ренин-ангиотензин - kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

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)

bayer ag - riociguat - Хипертония, белодробна - Антихипертензивни средства за белодробна артериална хипертония - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. Ефективността е демонстрирана в популацията уф включително етиология идиопатична или наследствени или пфу пфу, свързани с болести на съединителната тъкан . paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.