Европейски съюз - български - 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.

Европейски съюз - български - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - 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 - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma 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. vegzelma 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 vegzelma in combination with capecitabine. За допълнителна информация относно статуса на her2, моля, вижте раздел 5. vegzelma, 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 (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, 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. vegzelma, 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 vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma 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. vegzelma, 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.

Европейски съюз - български - EMA (European Medicines Agency)

astrazeneca ab - olaparib - Овариални неоплазми - Антинеопластични средства - Яйчниците cancerlynparza включен като монотерапии за:подкрепа на лечение на възрастни пациенти с късни (фиго етапи iii и iv) в гените brca1/2-мутирали (зародышевой линия и/или соматични) высокосортная епител на яйчника, маточната тръба или начална перитонеална рак, които в отговор (пълна или частична) след приключване на първа линия на базата на платина химиотерапия. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 и 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. Пациентите трябва предварително са обработени с антрациклина и таксана в (нео)помощните или метастатический, ако пациентите не са подходящи за тези процедури (виж раздел 5. Пациентите с рецептор хормон (ч)-положителен рак на гърдата трябва също така да развиват или след предварителна хормонална терапия, или се считат за неподходящи за ендокринна терапия. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Европейски съюз - български - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - Антинеопластични средства - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Европейски съюз - български - EMA (European Medicines Agency)

amgen technology (ireland) uc - бевацизумаб - carcinoma, renal cell; peritoneal neoplasms; ovarian neoplasms; breast neoplasms; carcinoma, non-small-cell lung; fallopian tube neoplasms - Антинеопластични средства - mvasi в комбинация с химиотерапия на базата на флуоропиримидин е показан за лечение на възрастни пациенти с метастазен карцином на дебелото черво или ректума. mvasi в комбинация с паклитаксел е показан за първа линия на лечение при 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. mvasi, в допълнение към платин-базирана химиотерапия, е предназначен за първа линия на лечение на възрастни пациенти с нерезектабельными-често, метастазирал или рецидивирующим немелкоклеточным рак на белите дробове, отколкото други са в основата на плоскоклеточной гистологией. mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. mvasi, в комбинация с карбоплатин и паклитаксел е показан за предната линия на лечение на възрастни пациенти с напреднал (Международната федерация на акушерството и гинекология (figo) етап ІІІБ, МНКР и iv) епител на яйчника, маточната тръба или начална перитонеална рак . mvasi, в комбинация с карбоплатином и гемцитабином или в комбинация с карбоплатином и паклитакселом, е показан за лечение на възрастни пациенти с първия рецидив платиночувствительный епител на яйчниците, фалопиевите тръби или първичен перитонеальным с рак, които не са получавали преди това терапия бевацизумабом или други инхибитори на Фрэс или vegf рецептор-мишена агенти. mvasi 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. mvasi, 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.

Европейски съюз - български - EMA (European Medicines Agency)

mylan ire healthcare 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 - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Европейски съюз - български - 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.

Европейски съюз - български - EMA (European Medicines Agency)

sandoz gmbh - епоетин алфа - anemia; kidney failure, chronic - Антианемични препарати - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis;, treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. състоянието на сърдечно-съдовата система, на вече съществуваща анемия в началото на химиотерапия).

Европейски съюз - български - EMA (European Medicines Agency)

hexal ag - епоетин алфа - anemia; kidney failure, chronic; cancer - Антианемични препарати - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Лечение на анемия и намаляване на нуждите от преливане на кръв при възрастни пациенти, приемащи химиотерапия на солидни тумори, малигнен лимфом или множествена миеломы, както и на риска от трансфузии оцениваемым общото състояние на пациента (e. състоянието на сърдечно-съдовата система, на вече съществуваща анемия в началото на химиотерапия).

Европейски съюз - български - EMA (European Medicines Agency)

sanofi b.v. - севеламер - renal dialysis; hyperphosphatemia - Всички други терапевтични продукти - renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis. renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.