Bulgarija - bulgarų - БАБХ (Българска агенция по безопасност на храните)

sp veterinaria s.a - Колистин (сулфат) - премикс за медикаментозен фураж - 10 g/100 g - свине

Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

mendelikabs europe ltd - нитисинона - tyrosinemias - Други стомашно-чревния тракт и обмяната на веществата средства, - Лечение на възрастни и педиатрични пациенти (във възрастов диапазон) с потвърдена диагноза наследствена тирозинемия тип 1 (НТ1) в комбинация с диетично ограничаване на тирозин и фенилаланин.

Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - Левкемия, лимфоцитна, хронична, В-клетка - Антинеопластични средства - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - dalbavancin hydrochloride - soft tissue infections; skin diseases, bacterial - Антибактериални средства за подаване на заявления, - Лечение на остри бактериални инфекции на кожата и кожната структура (absssi) при възрастни.

Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - epcoritamab - lymphoma, large b-cell, diffuse - Антинеопластични средства - tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) after two or more lines of systemic therapy.

Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - Антинеопластични средства - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - невирапин - ХИВ инфекции - Антивирусни средства за системно приложение - Хапчета и устни suspensionviramune е посочено в комбинация с други антиретровирусными лекарствени средства за лечение на hiv-1 инфектирани възрастни, юноши и деца на всяка възраст. По-голямата част от опита с Вирамун в комбинация с нуклеозидными на обратната транскриптаза (nrti). Избор на последваща терапия след Вирамун трябва да се основава на клинично опит и тест на съпротива . 50 и 100 mg с удължено освобождаване на tabletsviramune е посочено в комбинация с други антиретровирусными лекарствени средства за лечение на hiv-1 инфектирани юноши и деца на възраст три и повече години и е в състояние поглъщане хапчета. Удължен съобщение таблетки не са подходящи за 14-дневен въвеждане етапа на пациентите, като се започне невирапин. Други невирапин лекарства, като например незабавното освобождаване на таблетки или пероральная суспензия трябва да се използва. По-голямата част от опита с Вирамун в комбинация с нуклеозидными на обратната транскриптаза (nrti). Избор на последваща терапия след Вирамун трябва да се основава на клинично опит и тест на съпротива . 400-mg с удължено освобождаване на tabletsviramune е посочено в комбинация с други антиретровирусными лекарствени средства за лечение на hiv-1 инфектирани възрастни, юноши и деца на възраст три и повече години и е в състояние поглъщане хапчета. Удължен съобщение таблетки не са подходящи за 14-дневен въвеждане етапа на пациентите, като се започне невирапин. Други невирапин лекарства, като например незабавното освобождаване на таблетки или пероральная суспензия трябва да се използва. По-голямата част от опита с Вирамун в комбинация с нуклеозидными на обратната транскриптаза (nrti). Избор на последваща терапия след Вирамун трябва да се основава на клинично опит и тест на съпротива .

Europos Sąjunga - bulgarų - 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.

Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

teva gmbh - филграстим - neutropenia; hematopoietic stem cell transplantation; cancer - Иммуностимуляторы, - tevagrastim е показан за намаляване продължителността на неутропения и честотата на фебрилна неутропения при пациенти, лекувани с установените цитотоксична химиотерапия за злокачествено заболяване (с изключение на Хроничната миелоидна левкемия и остра миелоидна синдроми) и за намаляване на продължителността на неутропения при пациенти, подложени на myeloablative терапия последвана от костно-мозъчна трансплантация се с повишен риск от продължителен тежка неутропения. Безопасността и ефективността на прилагане на филграстима са подобни при възрастни и деца, подложени на химиотерапия цитотоксическую. tevagrastim е предназначен за мобилизиране на клетките-предшественици на периферна кръв (pbpc). При пациенти, деца и възрастни с тежка вродена, циклична или идиопатична нейтропении на абсолютния брой на неутрофилите (anc) 0. 5 х 109/л, и анамнеза за тежки или рецидивиращи инфекции, в дългосрочен план администрация tevagrastim се посочва в увеличение на неутрофилите и намаляване честотата и продължителността на инфекциозните събития. tevagrastim е показан за лечение на устойчиви неутропения (anc по-малко или равно на 1. 0 x 109/l) при пациенти с напреднала hiv инфекция, за намаляване на риска от бактериални инфекции, когато други опции за управление на неутропения са неподходящи.

Europos Sąjunga - bulgarų - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - тиотепа - hematopoietic stem cell transplantation; neoplasms - Антинеопластични средства - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.