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.

България - български - Изпълнителна агенция по лекарствата

Тева Фармасютикълс България ЕООД - Комбинация - 500 mg/200 mg/10 mg powder for oral solution

Европейски съюз - български - EMA (European Medicines Agency)

recordati ireland ltd - силодозин - Простатна хиперплазия - urologicals - Лечението на признаците и симптомите на доброкачествена простатна хиперплазия (БПХ).

Европейски съюз - български - EMA (European Medicines Agency)

recordati ireland ltd - силодозин - Простатна хиперплазия - urologicals - Лечението на признаците и симптомите на доброкачествена простатна хиперплазия (БПХ).

Европейски съюз - български - EMA (European Medicines Agency)

recordati ireland ltd - силодозин - Простатна хиперплазия - urologicals, алфа-адренорецепторите антагонисти - Лечение на признаците и симптомите на доброкачествена простатической хиперплазия (bph) при мъже на възраст.

Европейски съюз - български - EMA (European Medicines Agency)

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.

Европейски съюз - български - EMA (European Medicines Agency)

n.v. organon - деслоратадин - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - Антихистамини за системно приложение, - azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5. 1)urticaria (see section 5.

Европейски съюз - български - EMA (European Medicines Agency)

ratiopharm gmbh - деслоратадин - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - Антихистамини за системно приложение, - desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician.

Европейски съюз - български - EMA (European Medicines Agency)

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.

Европейски съюз - български - EMA (European Medicines Agency)

mylan pharmaceuticals limited - фебуксостат - hyperuricemia; arthritis, gouty; gout - Препарати против изгаряне - febuxostat mylan е показан за профилактика и лечение на hyperuricaemia при възрастни пациенти, подложени на химиотерапия за хематологични неоплазии на среден към висок риск на тумора lysis синдром (tls). Фебуксостат mylan в е показан за лечение на хронична гиперурикемии в условия, когато уратные натрупвания вече имаше (включително и в миналото, или наличието, отлагането на соли и/или подагрического артрит). Фебуксостат mylan в е показан за възрастни.