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)

albireo - odevixibat - cholestasis, intrahepatic - Болест и чернодробна терапия - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or older (see sections 4. 4 и 5.

Европейски съюз - български - EMA (European Medicines Agency)

serb sa - амифампридинов - Миастеничен синдром на lambert-eaton - Други лекарства в нервната система - Симптоматично лечение на миастенен синдром на lambert-eaton (lems) при възрастни.

Европейски съюз - български - EMA (European Medicines Agency)

serb sa - amifampridine phosphate - lambert-eaton myasthenic syndrome; paraneoplastic syndromes, nervous system; nervous system neoplasms; paraneoplastic syndromes; nervous system diseases; autoimmune diseases of the nervous system; neurodegenerative diseases; neuromuscular diseases; neuromuscular junction diseases; immune system diseases; autoimmune diseases; autoimmune diseases of the nervous system; cancer; neoplasms - Други лекарства в нервната система - Симптоматично лечение на миастенен синдром на lambert-eaton (lems) при възрастни.

Европейски съюз - български - EMA (European Medicines Agency)

bayer ag  - octocog Алфа - Хемофилия А - Антихеморагични - Лечение и профилактика на кървене при пациенти с хемофилия А (вродена дефицит на фактор vІІІ). Този препарат не съдържа фактор Виллебранда и затова не е посочено в болестта на фон Виллебранда .

Европейски съюз - български - EMA (European Medicines Agency)

bayer animal health gmbh  - прадофлоксацин - Антибактериални средства за подаване на заявления, фторхинолоны - dogs; cats - dogstreatment от:раневых на инфекции, причинени от чувствителни щамове на staphylococcus Интер Групи (включително. pseudintermedius);повърхностни и дълбоки пиодермии, причинени от чувствителни щамове на staphylococcus Интер Групи (включително. pseudintermedius);остри инфекции на пикочните пътища, причинени от чувствителни щамове на escherichia coli и staphylococcus Интер Групи (включително. pseudintermedius);като допълнителна терапия към механично или хирургическа пародонтологического лечение при лечение на тежки инфекции на венците и околозубных на тъканите, причинени от чувствителни щамове на анаеробни организми, например, porphyromonas). и prevotella spp. catstreatment остри инфекции на горните дихателни пътища, причинени от чувствителни щамове на бактерии, pasteurella multocida, escherichia coli и staphylococcus Интер Групи (включително. pseudintermedius).

Европейски съюз - български - EMA (European Medicines Agency)

bayer ag - octocog Алфа - Хемофилия А - Антихеморагични - Лечение и профилактика на кървене при пациенти с хемофилия А (дефицит на вроден дефицит на фактор vІІІ). iblias може да се използва за всички възрастови групи.

Европейски съюз - български - EMA (European Medicines Agency)

bayer ag - riociguat - Хипертония, белодробна - Антихипертензивни средства за белодробна артериална хипертония - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. Ефективността е демонстрирана в популацията уф включително етиология идиопатична или наследствени или пфу пфу, свързани с болести на съединителната тъкан . paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.

Европейски съюз - български - EMA (European Medicines Agency)

bayer ag  - варденафил - Ерективна дисфункция - urologicals - Лечение на еректилна дисфункция при възрастни мъже. Ерективната дисфункция е невъзможността да се постигне или поддържа ерекция на пениса, достатъчна за задоволително сексуално представяне. За да levitra е било ефективно, е необходимо сексуално стимулиране . levitra не е показан за употреба от жени.

Европейски съюз - български - EMA (European Medicines Agency)

bayer ag - сорафениб - carcinoma, hepatocellular; carcinoma, renal cell - Антинеопластични средства - Гепатоцеллюлярная carcinomanexavar е показан за лечение на карцином гепатоцеллюлярной. Почечно-клетъчен carcinomanexavar е показан за лечение на пациенти с честата почечно-клетъчен карцином, които не по-рано от интерферон-алфа или интерлевкин-2 терапия или се считат за неподходящи за такава терапия. Диференциала на щитовидната жлеза carcinomanexavar е показан за лечение на пациенти с белег, локално-напреднал или метастазирал, диференцирани (папиллярный/фолликулярный/hürthle клетъчния) рак на щитовидната жлеза, рефрактерным до радиоактивному Йоду.