Европейский союз - польский - EMA (European Medicines Agency)

gilead sciences ireland uc - bulevirtide acetate - hepatitis d, chronic - Środki przeciwwirusowe do użytku ogólnoustrojowego - hepcludex is indicated for the treatment of chronic hepatitis delta virus (hdv) infection in plasma (or serum) hdv-rna positive adult patients with compensated liver disease.

Европейский союз - польский - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - odrzucenie wniosku - leki immunosupresyjne - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Европейский союз - польский - EMA (European Medicines Agency)

amgen europe bv - sotorasib - rak, niedrobnokomórkowe płuca - Środki przeciwnowotworowe - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.

Европейский союз - польский - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - stwardnienie rozsiane, Рецидивно-znika - leki immunosupresyjne - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Европейский союз - польский - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - stwardnienie rozsiane, Рецидивно-znika - leki immunosupresyjne selektywne leki immunosupresyjne - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Европейский союз - польский - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolakton - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 i 5.

Европейский союз - польский - EMA (European Medicines Agency)

bavarian nordic a/s - zmodyfikowany wirus krowianki ankara - wirus bawaryjski nordycki (mva-bn) - smallpox vaccine; monkeypox virus - innych szczepionek wirusowych, - active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4. 4 i 5. stosowanie tej szczepionki powinno odbywać się zgodnie z oficjalnymi zaleceniami.

Европейский союз - польский - EMA (European Medicines Agency)

prevtec microbia gmbh - żywe niepatogenne escherichia coli o8: k87 - immunologicals for suidae, live bacterial vaccines, pig - wieprzowy - dla aktywnych szczepień świń przeciwko энтеротоксигенных Ф4-dodatnich escherichia coli w celu:zmniejszenia zachorowalności umiarkowanego do ciężkiego po odstawieniu escherichia coli biegunka (frd) w świnie;zmniejszenie kolonizacji w jelita krętego i kału przelania энтеротоксигенных Ф4-dodatnich escherichia coli od zakażonych świń.

Европейский союз - польский - EMA (European Medicines Agency)

elanco gmbh - Żywe niepatogenne escherichia coli o141: k94 (f18ac) i o8: k87 (f4ac) - immunologicals for suidae, live bacterial vaccines - wieprzowy - do czynnej immunizacji świń w wieku 18 dni przeciwko enterotoksynnym f4-dodatnim i f18-dodatnim escherichia coli w celu zmniejszenia częstości występowania umiarkowanego do ciężkiego po odsadzeniu od matki. jeśli biegunka (frd) w zakażonych świń i redukcji kału przelania энтеротоксигенных Ф4-pozytywne i f18-pozytywne e. coli z zakażonych świń.

Европейский союз - польский - EMA (European Medicines Agency)

intervet international b.v. - Żywiący się rekombinowanym indyczym herpeswirusem (szczep hvt / ilt-138) powiązany z komórką, wyrażający glikoproteiny gd i gi zakaźnego wirusa zapalenia krtani i tchawicy - immunomodulatorów dla Авес żywych szczepionek wirusowych - kurczak - do czynnej immunizacji jednodniowych piskląt w celu zmniejszenia śmiertelności, objawów klinicznych i zmian chorobowych spowodowanych zakażeniem ptasim zakaźnym zapaleniem krtani i tchawicy (ilt) oraz wirusem choroby marchego (md).