Европейски съюз - български - EMA (European Medicines Agency)

intervet international b.v. - cell-associated live recombinant turkey herpesvirus (strain hvt/ndv/ilt) expressing the fusion protein of newcastle disease virus and the glycoproteins gd and gi of infectious laryngotracheitis virus - Имунологични за аве - embryonated chicken eggs; chicken - for active immunisation of one-day-old chicks or embryonated chicken eggs:to reduce mortality and clinical signs caused by newcastle disease (nd) virus,to reduce mortality, clinical signs and lesions caused by avian infectious laryngotracheitis (ilt) virus and marek’s disease (md) virus.

Европейски съюз - български - 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.

Европейски съюз - български - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - монохидрат Имипенем, циластатин натрий, relebactam монохидрат - Грамотрицательные Бактериални Инфекции - carbapenems, antibacterials for systemic use, - recarbrio is indicated for:- treatment of hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap), in adults (see sections 4. 4 и 5. - treatment of bacteraemia that occurs in association with, or is suspected to be associated with hap or vap, in adults. - treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options (see sections 4. 2, 4. 4 и 5. Трябва да се вземат предвид официалните препоръки за правилното използване на антибактериални агенти.

Европейски съюз - български - EMA (European Medicines Agency)

janssen-cilag international nv - дарунавир - ХИВ инфекции - Антивирусни средства за системно приложение - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Европейски съюз - български - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - левофлоксацин - cystic fibrosis; respiratory tract infections - Антибактериални средства за подаване на заявления, - quinsair е показан за лечение на хронични белодробни инфекции, причинени от pseudomonas инфекция при възрастни пациенти с муковисцидозом. Трябва да се вземат предвид официалните препоръки за правилното използване на антибактериални агенти.

Европейски съюз - български - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - сулфат ceftolozane, тазобактам натрий - Бактериални инфекции - Антибактериални средства за подаване на заявления, - zerbaxa is indicated for the treatment of the following infections in adults:complicated intra abdominal infections;acute pyelonephritis;complicated urinary tract infections;hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap). Трябва да се вземат предвид официалните препоръки за правилното използване на антибактериални агенти.

Европейски съюз - български - EMA (European Medicines Agency)

pfizer ireland pharmaceuticals - avibactam sodium, ceftazidime pentahydrate - pneumonia, bacterial; soft tissue infections; pneumonia; urinary tract infections; gram-negative bacterial infections - Антибактериални средства за подаване на заявления, - zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:complicated intra-abdominal infection (ciai)complicated urinary tract infection (cuti), including pyelonephritishospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap)treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. zavicefta is also indicated for the treatment of infections due to aerobic gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. Трябва да се вземат предвид официалните препоръки за правилното използване на антибактериални агенти.

Европейски съюз - български - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - Меропенем тригидрат, vaborbactam - urinary tract infections; bacteremia; bacterial infections; respiratory tract infections; pneumonia; pneumonia, ventilator-associated - Антибактериални средства за подаване на заявления, - vaborem е показан за лечение на следните инфекции при възрастни:трансфери инфекция на пикочните пътища (кути), включително pyelonephritiscomplicated интраабдоминальные инфекция (ciai)внутрибольничные пневмония (Хэп), включително и на фен-ассоциированная пневмония (ВАП). Лечение на пациенти бактериемия, която възниква във връзка с, или подозират да бъдат свързани с всяко от посочените по-горе инфекции. vaborem също така е показан за лечение на инфекции, причинени от аэробными грамотрицательными микроорганизми при възрастни с ограничени възможности за лечение . Трябва да се вземат предвид официалните препоръки за правилното използване на антибактериални агенти.

Европейски съюз - български - EMA (European Medicines Agency)

laboratorios hipra s.a. - escherichia coli j5 inactivated, staphylococcus aureus (cp8) strain sp 140 inactivated, expressing slime-associated antigenic complex - Имунологични средства за животни от рода на едрия рогат добитък - Говеда (крави и юници) - За стадо имунизация на здрави крави и юници млечни породи едър рогат добитък, с повтарящи се маститов проблеми, за да се намали честотата на субклинических маститов и честотата и тежестта на клиничните симптоми клиничен мастит, причинен от златист Стафилококком, e. coli и коагулазонегативные стафилококи. Пълната имунизационна схема индуцира имунитет от приблизително 13-ия ден след първата инжекция до приблизително 78-ия ден след третата инжекция (еквивалентна на 130 дни след раждането).

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.