Union européenne - bulgare - EMA (European Medicines Agency)

pinnacle biologics b.v.  - натрий porfimer - Хранопровод На Барет - Антинеопластични средства - Фотодинамична терапия (ФДТ) с photobarr е предназначен за: премахване на тежка дисплазия (ГГД) при пациенти с хранопровода на Барет (БО).

Union européenne - bulgare - 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.

Union européenne - bulgare - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - арипипразол - schizophrenia; bipolar disorder - психолептици - abilify е показан за лечение на шизофрения при възрастни и юноши на възраст 15 и повече години. Абилифай е показан за лечение на умерени и тежки епизоди на мания при биполярном разстройство и за профилактика на нов маниакальный епизод при възрастни, които са имали предимно маниакальные епизоди и чиито маниакальные епизоди отговорили на лечение арипипразолом. Абилифай е показан за лечение до 12 седмици умерена и тежка мания епизоди на биполярно разстройство при юноши на възраст от 13 години и по-възрастни.

Union européenne - bulgare - EMA (European Medicines Agency)

csl behring gmbh - албутрепеннаког алфа - Хемофилия Б - Антихеморагични - Лечение и профилактика на кървене при пациенти с хемофилия В (дефицит на вроден дефицит на фактор ix).

Union européenne - bulgare - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - Толваптан - Полицистичен бъбрек, автозомно господстващо - Диуретици, - jinarc е показан да забави прогресията на киста развитие и бъбречна недостатъчност на автозомно господстващо поликистоза на бъбречно заболяване (adpkd) при възрастни с ПЦП етап 1-3 при започване на лечение с доказателства за бързо напредват болест.

Union européenne - bulgare - EMA (European Medicines Agency)

csl behring gmbh - лококтоког алфа - Хемофилия А - Антихеморагични - Лечение и профилактика на кървене при пациенти с хемофилия А (дефицит на вроден дефицит на фактор vІІІ). afstyla може да се използва за всички възрастови групи.

Union européenne - bulgare - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - Толваптан - Неподходящ синдром на adh - Диуретици, - Лечение на възрастни пациенти с хипонатриемия вследствие на синдром на неправилна секреция на антидиуретичен хормон (siadh).

Union européenne - bulgare - EMA (European Medicines Agency)

csl behring gmbh - Коагуляционного фактора човек viii, фактор Виллебранда човек - hemophilia a; von willebrand diseases - blood coagulation factors, von willebrand factor and coagulation factor viii in combination, antihemorrhagics - Болестта Виллебранда (vwd)профилактика и лечение на кръвоизливи и хирургически кръвоизливи при пациенти с vwd, когато Десмопрессин (ddavp) е един за лечение са неефективни или противопоказани. Хемофилия в (вроден фактор viii вида недостатъчност)профилактика и лечение на кръвоизливи при пациенти с хемофилия А.

Union européenne - bulgare - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - brexpiprazole - шизофрения - психолептици - Лечение на шизофренията.

Union européenne - bulgare - EMA (European Medicines Agency)

baxalta innovations gmbh - vonicog Алфа - болестите на фон Вилебранд - Антихеморагични - veyvondi е показан за възрастни (на възраст 18 и повече години) при болестта на Виллебранда (vwd), когато Десмопрессин (ddavp) на едно лечение е неефективно или не е показан за лечение на кръвоизливи и хирургично кървене - профилактика хирургично кървене. veyvondi не трябва да се използва в лечението на хемофилия А.