Európska únia - bulharčina - EMA (European Medicines Agency)

novartis europharm limited - brinzolamide, тимолола малеат - glaucoma, open-angle; ocular hypertension - Офталмологични - Намаляване на вътреочното налягане (ВОН) при възрастни пациенти с откритоъгълна глаукома или внутриглазной хипертония, за които монотерапия предоставя недостатъчно намаляване на ВОН.

Európska únia - bulharčina - EMA (European Medicines Agency)

novartis europharm limited - Канакинумаб - cryopyrin-associated periodic syndromes; arthritis, juvenile rheumatoid; arthritis, gouty - Инхибитори на интерлевкин, - Периодичната треска syndromesilaris е показан за лечение на следните периодични аутовоспалительные синдроми треска при възрастни, юноши и деца на възраст 2 години и повече:криопиринассоциированные периодични syndromesilaris е показан за лечение на криопиринассоциированные периодични синдроми (шапки) в това число:Макла-Уэллса синдром (СМВ),новородени-началото на мультисистемное възпалително заболяване (НОМИД) / хроничен инфантильный неврологична, кожен, ставния синдром (cinca),тежки форми на семейна холодовая аутовоспалительные синдром (fcas) / фамилна холодовая уртикария (fcu) въвеждане с Признаци и симптоми на студ-индуцирана уртикарной обриви . Тумор на рецептори на фактора некроза е свързан периодичен синдром (капани)Иларис е показан за лечение на некротизиращ (tnf) рецептор е свързан периодичен синдром (капани). Синдром на hyperimmunoglobulin Д (разделени) дефицит/мевалонат киназы (МКД)Иларис е предназначен за лечение на синдром на hyperimmunoglobulin Д (разделени) дефицит/мевалонат киназы (МКД). Фамилната средиземноморска треска (ФМФ)Иларис е показан за лечение на фамилна средиземноморска треска (ФМФ). Иларис трябва да се прилага в комбинация с други лекарствени средства, при необходимост. Иларис също така е показан за лечение на:още diseaseilaris е показан за лечение на активна болест на Стилла-Шоффара включително и зряла възраст, болест на Стилла-Шоффара (aop) и системен младежката идиопатична артрит (sjia) при пациенти на възраст 2 и повече години, които реагират неадекватно на предишната терапия нестероидни противовъзпалителни лекарства (НСПВС) и системни кортикостероидни. Иларис може да бъде дадено като монотерапии или в комбинация с метотрексат. Подагрозен arthritisilaris предписват за симптоматично лечение на възрастни пациенти с чести подагрозен артрит удари (не по-малко от 3 инфаркт в рамките на последните 12 месеца), които нестероидни противовъзпалителни средства (НСПВС) и колхицин са противопоказани, не се прехвърлят или не осигуряват адекватен отговор, в който повторни курсове на джи си ес не е препоръчително.

Európska únia - bulharčina - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - ритуксимаб - lymphoma, non-hodgkin; arthritis, rheumatoid; wegener granulomatosis; leukemia, lymphocytic, chronic, b-cell; microscopic polyangiitis - Антинеопластични средства - truxima, се посочва в възрастни по следните причини:неходжкинские лимфом (НХЛ)truxima е показан за лечение на по-рано не е получавала лечение на пациенти с iii стъпка, vi, фоликуларен лимфом в комбинация с химиотерапия. Ремонт truxima терапия е показан за лечение на пациенти с фоликуларен лимфомой, които попълват индукционную терапия. truxima монотерапии, предназначени за лечение на пациенти с iii етап iv на фоликулите лимфомой, които са Хемо-упорит или втори или следващ рецидив след химиотерапия. truxima е показан за лечение на пациенти с cd20 в положителна за разпространяване на крупноклеточной b в клетъчните не-ходжкинских лимфом в комбинация с chop (циклофосфамид, доксорубицин, Винкристин, преднизолон) химиотерапия. Хроничен лимфоцитарный левкемия (ХЛЛ)truxima в комбинация с химиотерапия е показано за обработка на пациенти с по-рано не е получавала лечение и relapsed/тугоплавким ХЛЛ. Налични са само ограничени данни за ефикасността и безопасността на пациенти, лекувани преди това с моноклонални антитела, включително truxima или пациенти, рефрактерни на предишни truxima плюс химиотерапия. Ревматоиден arthritistruxima в комбинация с метотрексат е показан за лечение на възрастни пациенти с тежък активен ревматоиден артрит, които са имали недостатъчен отговор или непоносимост към други заболяване дорабатывая анти-ревматични лекарства (dmards), включително един или повече фактор на некроза на тумора (tnf) инхибитор терапия. truxima доказано е, за да се намали скоростта на прогресия на ставите, измерена на рентгенова радиация и подобряване на физическата функция, когато се дава в комбинация с метотрексат. Гранулематоз с полиангиитом и микроскопично polyangiitistruxima, в комбинация с глюкокортикоидами, се предписва за лечение на възрастни пациенти с тежък активен гранулематоз с полиангиитом (Вегенера) (ГПА) и микроскопични полиангиитом (ИПП). Пузырчатка vulgaristruxima е показан за лечение на пациенти с умерена до тежка вулгарно пузырчатка (mf).

Európska únia - bulharčina - EMA (European Medicines Agency)

novo nordisk a/s - лираглутид - obesity; overweight - Лекарства, използвани при диабет - saxenda е показан като добавка към гипокалорийной диета и повишена физическа активност за контрол на теглото при възрастни пациенти с отворен индекс на телесна маса (ИТМ)• ≥ 30 кг/м2 (затлъстяване), или• ≥ 27 кг/м2 и < 30 кг/м2 (с наднормено тегло) при наличие на поне един тегло-ревюта на съпътстващи заболявания, като dysglycaemia (предиабет или диабет тип 2), артериална хипертония, дислипидемия или синдром на обструктивна сънна апнея. Лечение saxenda трябва да спре след 12 седмици 3. 0 мг/ден доза, ако пациентът не се губи, най-малко 5% от първоначалното тегло на тялото .

Európska únia - bulharčina - EMA (European Medicines Agency)

samsung bioepis nl b.v. - бевацизумаб - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Антинеопластични средства - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. За повече информация, както за човешкия рецептор на епидермален фактор за растеж 2 (her2 и) статут, моля, вижте раздел 5. 1 of the smpc. aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. За допълнителна информация относно статуса на her2, моля, вижте раздел 5. 1 of the smpc. aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. 1 of the smpc). aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. 1 of the smpc). aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5. 1 of the smpc).

Európska únia - bulharčina - EMA (European Medicines Agency)

centus biotherapeutics europe limited - бевацизумаб - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - Антинеопластични средства - bevacizumab в комбинация с химиотерапия на основата на флуоропиримидин е показан за лечение на възрастни пациенти с метастазен карцином на дебелото черво или ректума. Бевацизумаб в комбинация с паклитакселом е предназначен за първа линия на лечение на възрастни пациенти с метастазирал рак на млечната жлеза . За повече информация, както за човешкия рецептор на епидермален фактор за растеж 2 (her2 и) статут, моля, вижте раздел 5. Бевацизумаб в комбинация с капецитабином е предназначен за първа линия на лечение на пациенти с метастазирал рак на гърдата, при които лечението с други варианти на химиотерапия, включително таксаны или антрациклины, се счита за непрактично. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. За допълнителна информация относно статуса на her2, моля, вижте раздел 5. bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Бевацизумаб в комбинация с эрлотинибом, е предназначен за първа линия на лечение при възрастни пациенти с нерезектабельными-често, метастазирал или рецидивирующим неороговевающий немелкоклеточного рак на белия дроб с епидермален фактор на растежа (egfr) спомагателни мутации. bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. Бевацизумаб в комбинация с паклитакселом и цисплатином или паклитакселом и топотеканом при пациенти, които не могат да получат платиновую терапия, е показан за лечение на възрастни пациенти с персистираща, пристъпно или метастатичен медиална на шийката на матката.

Európska únia - bulharčina - EMA (European Medicines Agency)

samsung bioepis nl b.v. - бевацизумаб - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Антинеопластични средства - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. За повече информация, както за човешкия рецептор на епидермален фактор за растеж 2 (her2 и) статут, моля, вижте раздел 5. onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with onbevzi in combination with capecitabine. За допълнителна информация относно статуса на her2, моля, вижте раздел 5. onbevzi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Európska únia - bulharčina - EMA (European Medicines Agency)

mabxience research sl - бевацизумаб - colorectal neoplasms; breast neoplasms; ovarian neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Антинеопластични средства - alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. alymsys in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with alymsys in combination with capecitabine. alymsys, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. alymsys, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. alymsys, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. alymsys, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. alymsys, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. alymsys, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Európska únia - bulharčina - EMA (European Medicines Agency)

stada arzneimittel ag - бевацизумаб - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Антинеопластични средства - oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. За повече информация, както за човешкия рецептор на епидермален фактор за растеж 2 (her2 и) статут, моля, вижте раздел 5. oyavas in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with oyavas in combination with capecitabine. За допълнителна информация относно статуса на her2, моля, вижте раздел 5. oyavas, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. oyavas, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. oyavas, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. oyavas, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. oyavas, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. oyavas, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Európska únia - bulharčina - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - бевацизумаб - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Антинеопластични средства - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. За повече информация, както за човешкия рецептор на епидермален фактор за растеж 2 (her2 и) статут, моля, вижте раздел 5. abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. За допълнителна информация относно статуса на her2, моля, вижте раздел 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.