Европейски съюз - български - EMA (European Medicines Agency)

novo nordisk a/s - eptacog alfa (активиран) - hemophilia b; thrombasthenia; factor vii deficiency; hemophilia a - Антихеморагични - Новосэвен се предписват за лечение на епизоди на кървене и профилактика на кръвоизливи при хора, подложени на хирургични интервенции или инвазивни процедури в следните групи пациенти:при пациенти с вродена хемофилия с инхибитори на фактори на съсирване на viii или ix > 5 Бетезда единици (bu);при пациенти с вродена хемофилия, които се очаква да имат най-висок анамнестических отговор на фактор viii или фактор ix век, администрацията;при пациенти с придобити хемофилия;при пациенти с вродени фактор-vii-аз дефицит;при пациенти с тромбастенией Гланцманна с антитела към тромбоцитарных гликопротеини (gp) iib-ІІІа и / или антигени на белите кръвни клетки на човека (НlА), и в миналото или настоящето рефрактерности до трансфузиям тромбоцитарной маса. при пациенти с тромбастенией Гланцманна С миналото или настоящето рефрактерности до трансфузиям тромбоцитарной маса, или където те не са лесно достъпни.

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

laboratorios hipra, s.a - Вирус гана, щам lederle, отслабва; парвовирус кучета (cpv), на щам с - 780916, са отслабени; кученце adenovirus 2 (kad - 2), щам на Манхатън; вируса на кучешки, parainfluenza (cpiv), прецедете Пен 103/70, отслабени - инжекционна суспунзия - ≥ 10 на степен 4 tcid50; ≥ 10 на степен 6 tcid50; ≥ 10 на степен 4 tcid50; ≥ 10 на степен 5 tcid50 - кучета

Европейски съюз - български - EMA (European Medicines Agency)

sanofi winthrop industrie - клопидогрел хидрогенсулфат - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - Антитромботични агенти - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;adult patients suffering from acute coronary syndrome:non-st-segment-elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);st-segment-elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. Предотвратяване на атеротромботических и тромбоемболични събития при предсърдно fibrillationin възрастни пациенти с фибрилляцией мъждене, които имат поне един рисков фактор за развитие на съдови събития, не са подходящи за лечение на витамин К-антагонисти и които имат по-нисък риск от кървене, клопидогрел е показан в комбинация с ВЪЗХОДЯЩО за профилактика атеротромботических и тромбоемболични събития, включително инсулт.

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. - caspofungin (as acetate) - candidiasis; aspergillosis - Антимикотици за системна употреба - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Европейски съюз - български - EMA (European Medicines Agency)

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f - pneumococcal infections; immunization - Ваксини - Активна имунизация за предотвратяване на инвазивни заболявания, пневмония и остър отит на средното ухо, причинени от streptococcus pneumoniae при бебета, деца и юноши от 6 седмици до 17 годишна възраст. Активна имунизация за профилактика на инвазивни заболявания, причинени от streptococcus pneumoniae при възрастни ≥18 години и по-възрастни хора. Вижте раздели 4. 4 и 5. 1 за информация относно защитата срещу специфични пневмококови серотипове. Използването на Превенар 13 трябва да се определи въз основа на официални препоръки, като се вземе предвид рискът от инвазивни заболявания в различните възрастови групи, в основата на съпътстващи заболявания, както и вариабельность серотипа на епидемиологията в различни географски райони.

Европейски съюз - български - EMA (European Medicines Agency)

pfizer limited - pneumococcal oligosaccharide serotype 18c, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14 - pneumococcal infections; immunization - Ваксини - Активна имунизация срещу болест, причинена от streptococcus pneumoniae серотипове 4, 6b, 9v, 14, 18 c, 19е и 23f (включително сепсис, менингит, пневмония, бактериемия и остър отит) при бебета и деца от два месеца до пет години на възраст. Използването на Превенар трябва да се определя въз основа на официални препоръки, като се вземе предвид влиянието на инвазивни заболявания в различните възрастови групи, както и променливостта на серотип на епидемиологията в различни географски райони.

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

ФАРМА ВЕТ ООД - а - Токоферол ацетат (Вит. Д); информация selenis; холекальциферол (Вит. Д3) - перорална емулсия - 2, 500 g/100 ml; 0, 063 g/100 ml; 0, 060 g/100 ml - агнета, говеда, зайци, кози, кокошки, кучета, овце, пилета, прасета, птици, пуйки, свине, телета, ярета

Европейски съюз - български - EMA (European Medicines Agency)

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 8, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 10a, pneumococcal polysaccharide serotype 11a, pneumococcal polysaccharide serotype 12f, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 15b, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 22f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 33f - Пневмококови инфекции - Ваксини - active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. Вижте раздели 4. 4 и 5. 1 за информация относно защитата срещу специфични пневмококови серотипове. apexxnar should be used in accordance with official recommendations. .

България - български - Изпълнителна агенция по лекарствата

proenzi s.r.o. - Глюкозамин - 1500 mg film - coated tablets