Европейски съюз - български - 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).

Европейски съюз - български - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - clopidogrel (as hydrogen sulfate) - stroke; peripheral vascular diseases; myocardial infarction; acute coronary syndrome - Антитромботични агенти - Клопидогрел е показан за възрастни за профилактика на атеротромботических събития:- пациенти, страдащи от 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. - Пациенти, страдащи от остър коронарным синдром:без вдигане на сегмента st остър коронарный синдром (нестабилна стенокардия или не-q-инфарктом на миокарда), включително пациенти, подложени на поставянето на стента след чрескожного коронарна интервенция, в комбинация с ацетилсалицилова киселина (ask). Възхода на сегмента st остър инфаркт на миокарда, в комбинация с ВЪЗХОДЯЩО в лечението на пациенти, които имат право на тромболитической терапия.

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)

pharmathen s.a. - мемантин хидрохлорид - Болест на Алцхаймер - psychoanaleptics и други анти-деменция лекарства - Лечение на пациенти с умерена до тежка болест на Алцхаймер.

Европейски съюз - български - EMA (European Medicines Agency)

pharmaand gmbh - дарифенацин хидробромид - urinary incontinence, urge; urinary bladder, overactive - urologicals, лекарства за уриниране и инконтиненция - Симптоматично лечение на импулсна инконтиненция и / или повишена честота и спешност в урината, които могат да се появят при възрастни пациенти с синдром на свръхактивен пикочен мехур.

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

boehringer ingelheim animal health france scs - Вирус е инфекциозен бронхит (ibv), на живо, щам х120 - замразена суспензия за пулверизиране - 3.7 до 4.7 log10 eid50 - пилета

Европейски съюз - български - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - Хиперхолестеролемия - Липидни модифициращи агенти - lojuxta е посочено като допълнение към диета с low‑fat и други lipid‑lowering лекарствени продукти, със или без ниско density липопротеин (ldl) аферезис при възрастни пациенти с хомозиготна недостатъчност Фамилна хиперхолестеролемия (hofh). Генетично потвърждение на hofh трябва да бъде получена от възможности. Други форми на първоначалните гиперлипопротейнемия и вторичните причини за хиперхолестеролемия (e. нефротический синдром, хипотиреоидизъм), трябва да бъдат изключени.

Европейски съюз - български - EMA (European Medicines Agency)

sandoz gmbh - адалимумаб - arthritis, rheumatoid; arthritis, psoriatic; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; arthritis, juvenile rheumatoid; crohn disease; skin diseases, papulosquamous - Имуносупресори - rheumatoid arthritishyrimoz in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hyrimoz може да бъде дадено като монотерапии в случай на непоносимост към метотрексат или при продължително лечение с метотрексат е неподходящо. Адалимумаб, както е показано, за да се намали скоростта на прогресия на увреждане на ставите как се измерва с рентгенови и подобряване на физическата функция при назначаването в комбинация с метотрексат. juvenile idiopathic arthritis- polyarticular juvenile idiopathic arthritishyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). hyrimoz може да бъде дадено като монотерапии в случай на непоносимост към метотрексат или при продължително лечение с метотрексат е неподходящо. Адалимумаб не е проучена обстойно при пациенти на възраст по-малко от 2 години. - enthesitis-related arthritishyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritis- ankylosing spondylitis (as)hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. - axial spondyloarthritis without radiographic evidence of ashyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. psoriatic arthritishyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Адалимумаб, както е показано, за да се намали скоростта на прогресия на периферната ставите, измерена с помощта на рентген при пациенти с полиартикулярным вариант симетрични подтипове на заболяване и за подобряване на физическата функция. psoriasishyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy. crohn’s diseasehyrimoz is indicated for treatment of moderately to severely active crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehyrimoz is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.  paediatric ulcerative colitishyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. ulcerative colitishyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitishyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.