Rapilysin Европейски съюз - български - EMA (European Medicines Agency)

rapilysin

actavis group ptc ehf - ретеплаза - Инфаркт на миокарда - Антитромботични агенти - rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent st elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (ami) symptoms.

DOXX-SOL 500 mg/g powder for use in drinking water/milk replacer for pre-ruminant calves, pigs and chickens 500 mg/g България - български - БАБХ (Българска агенция по безопасност на храните)

doxx-sol 500 mg/g powder for use in drinking water/milk replacer for pre-ruminant calves, pigs and chickens 500 mg/g

huvepharma nv - Доксициклин гиклат - прах за прилагане във вода за пиене - 500 mg/g - говеда, пилета, свине, телета

PAROFOR 140 mg/ml solution for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs 200 mg/ml България - български - БАБХ (Българска агенция по безопасност на храните)

parofor 140 mg/ml solution for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs 200 mg/ml

huvepharma nv - Сулфат паромомицин - разтвор за прилагане във водата за пиене/млако или млекозаместител - 200 mg/ml - говеда, прасета

Clopidogrel Teva Pharma B.V. Европейски съюз - български - EMA (European Medicines Agency)

clopidogrel teva pharma b.v.

teva pharma b.v.  - clopidogrel (as hydrobromide) - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - Антитромботични агенти - Предотвратяване на атеротромботических eventsclopidogrel е показан при възрастни пациенти, страдащи инфарктом инфаркт (от няколко дни до по-малко от 35 дни), исхемичен инсулт (от 7 дни до по-малко от 6 месеца) или установена заболяване на периферните артерии;при възрастни пациенти, страдащи от остър коронарным синдром: без възхода на сегмента st остър коронарный синдром (нестабилна стенокардия или не-q-инфаркт на миокарда), включително и на пациенти, подложени на стентирование след чрескожного коронарна интервенция, в комбинация с ацетилсалицилова киселина (ask);изместване на сегмента st остър инфаркт на миокарда, в комбинация с ВЪЗХОДЯЩО в лечението на пациенти, които имат право на тромболитической терапия. 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 (ВКА) и които имат по-нисък риск от кървене, клопидогрел е показан в комбинация с ВЪЗХОДЯЩО за профилактика атеротромботических и тромбоемболични събития, включително инсулт.

Opdivo Европейски съюз - български - EMA (European Medicines Agency)

opdivo

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.

Nemdatine Европейски съюз - български - EMA (European Medicines Agency)

nemdatine

actavis group ptc ehf. - мемантин - Болест на Алцхаймер - psychoanaleptics и други анти-деменция лекарства - Лечение на пациенти с умерена до тежка болест на Алцхаймер.

Elfabrio Европейски съюз - български - EMA (European Medicines Agency)

elfabrio

chiesi farmaceutici s.p.a - pegunigalsidase alfa - Фабри болест - Други стомашно-чревния тракт и обмяната на веществата средства, - elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of fabry disease (deficiency of alpha-galactosidase).

Flebogamma DIF (previously Flebogammadif) Европейски съюз - български - EMA (European Medicines Agency)

flebogamma dif (previously flebogammadif)

instituto grifols s.a. - Имуноглобулин нормален човек - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - Имунни серуми и имуноглобулини - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.