Европейски съюз - български - EMA (European Medicines Agency)

roche registration gmbh - ерлотиниб - carcinoma, non-small-cell lung; pancreatic neoplasms - Антинеопластични средства - Немелкоклеточный рак на белия дроб (НМРЛ)Тарцева също така показва, ремонт на ключа за лечение при пациенти с локално-напреднал или метастазирал немелкоклеточным рак на белите дробове с egfr активирате перегласовки и стабилен заболявания, след химиотерапия от първа линия. Тарцева също така е показан за лечение на пациенти с локално-напреднал или метастазирал немелкоклеточным рак на белите дробове, след неуспех на поне един от предишната схема на химиотерапия. При пациенти с тумори, без РСКФ спомагателни мутации, Тарцева е посочено, когато други възможности за лечение, не се считат. При назначаването на Тарцевы, фактори, свързани с продължително оцеляване трябва да се вземат предвид. Няма предимство за оцеляване или други клинично значими ефекти на лечението са били демонстрирани при пациенти с епидермален фактор на растежа (egfr)-hpcc - негативни тумори. cancertarceva на панкреаса в комбинация с гемцитабином е показан за лечение на пациенти с метастазирал рак на панкреаса . При назначаването на Тарцевы, фактори, свързани с продължително оцеляване трябва да се вземат предвид.

Европейски съюз - български - EMA (European Medicines Agency)

roche registration gmbh - окрелизумаб - Множествена склероза - Имуносупресори - Лечение на възрастни пациенти с релапсиращи форми на множествена склероза (rms) с активно заболяване, дефинирано по клинични или образни признаци. Лечение на възрастни пациенти с ранен първичен прогресивна множествена склероза (ППМС) по отношение на продължителността на заболяването и степента на увреждане, както и с помощта на визуализация черти, характерни за воспалительной активност.

Европейски съюз - български - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - Антинеопластични средства - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq като монотерапии е предназначен за лечение на възрастни пациенти с локално-напреднал или метастазирал НМРЛ след като по-рано химиотерапия. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq като монотерапии е предназначен за лечение на възрастни пациенти с локално-напреднал или метастазирал НМРЛ след като по-рано химиотерапия. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Европейски съюз - български - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab ведотин - Лимфом, b-Клетъчен - Антинеопластични средства - Полевий в комбинация с Бендамустин и технология на органичния синтез е показан за лечение на възрастни пациенти с пристъпно/продължителна разпространяване на В-крупноклеточной лимфомой (ДВККЛ), които не са кандидати за трансплантация на хемопоетични стволови клетки за трансплантация. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Европейски съюз - български - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - Антинеопластични средства - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Европейски съюз - български - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - Грип, Човек - Антивирусни средства за системно приложение - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

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)

roche registration gmbh  - risdiplam - Мускулна атрофия, спинална - Други лекарства за нарушения на мускулно-скелетната система - evrysdi is indicated for the treatment of 5q spinal muscular atrophy (sma) in patients with a clinical diagnosis of sma type 1, type 2 or type 3 or with one to four smn2 copies.

Европейски съюз - български - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - Имуносупресори - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Европейски съюз - български - EMA (European Medicines Agency)

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - Имунни серуми и имуноглобулини - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. Вижте раздели 4. 4 и 5.