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)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - Ваксини - active immunisation against h5 subtype of influenza a virus.

България - български - БАБХ (Българска агенция по безопасност на храните)

krka - Энрофлоксацин - перорален разтвор - 100 mg/ml - пилета, пуйки

Европейски съюз - български - EMA (European Medicines Agency)

seqirus s.r.l.  - антигени на повърхността на грипен вирус (хемаглутинин и нейраминидазы) напрежение: а/Турция/Турция/1/05 (Н5n1)-като напрежение (nibrg-23) - influenza, human; immunization; disease outbreaks - Ваксини - Активна имунизация срещу h5n1 подтип на грип-А вирус. Тази справка се основава на имуногенност на данни от здрави доброволци на възраст между 18 и следваща година след въвеждането на две дози от ваксината, съдържаща/Турция/Турция/1/05 (Н5n1)-като щамът. aflunov трябва да се прилага в съответствие с официалните препоръки.

Европейски съюз - български - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - Не повече от три от следните пречистена, инактивированная крака и уста болест щамове на вируса: О1 Маниса ≥ 6 pd50*; О1 БФС ≥ 6 pd50*; оа Тайван 3/97 ≥ 6 pd50*; А22 Ирак ≥ 6 pd50*; А24 Крузейро ≥ 6 pd50*; Турция 14/98 ≥ 6 pd50*; Азия-1 Шамир ≥ 6 pd50*; sat2 Саудитска Арабия ≥ 6 pd50*; * pd50 – 50% защитен прием на размножаване, както е описано по философия евро. 0063 петков. - Имунологични - pigs; cattle; sheep - Активна имунизация на едър рогат добитък, овце и прасета от 2 седмична възраст срещу шап за намаляване на клиничните признаци.

Европейски съюз - български - EMA (European Medicines Agency)

bavarian nordic a/s - модифицирана ваксиния Анкара - баварски северни (mva-bn) вируси - smallpox vaccine; monkeypox virus - Други вирусни ваксини, - active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4. 4 и 5. Използването на тази ваксина трябва да бъде приложена в съответствие с официалните препоръки.

Европейски съюз - български - EMA (European Medicines Agency)

zoetis belgium sa - Живият aroa ген заличава escherichia coli, тип 078, щам ec34195 - Имуномодулатори за птици, живи бактериални ваксини - chicken; turkeys - За активна имунизация на пилета-бройлери и бъдещи слоеве / животновъдите, за да се намали смъртността и поражението (перикарден излив, перигепатиты, airsacculitis), свързани с e. coli серотипа o78.

България - български - БАБХ (Българска агенция по безопасност на храните)

globul vet health sl - Амоксицилин - прах за прилагане във вода за пиене - 500 mg/g - патици, пилета, прасета, пуйки

България - български - БАБХ (Българска агенция по безопасност на храните)

andres pintaluba s.a. - Амоксициллина тригидрат - прах за прилагане във вода за пиене - 500 mg/g - бройлери, патици, прасета, пуйки

България - български - БАБХ (Българска агенция по безопасност на храните)

lohmann animal health - newcastle disease virus, live attenuated, strain clone 13-1 - лиофилизат за суспензия - 10 на степен 6.0 - 10 на степен 7.2 - пилета, пуйки