Filsuvez Unia Europejska - polski - EMA (European Medicines Agency)

filsuvez

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - preparaty do leczenia ran i owrzodzeń - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.

Zeffix Unia Europejska - polski - EMA (European Medicines Agency)

zeffix

glaxosmithkline (ireland) limited - lamiwudyna - wirusowe zapalenie wątroby typu b, przewlekłe - Środki przeciwwirusowe do użytku ogólnoustrojowego - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. początek leczenia lamiwudyną powinny być tylko w przypadku, gdy korzystanie z alternatywnych przeciwwirusowi agenci z wysokim genetycznym barierą nie są dostępne lub właściwe;, niewyrównaną chorobą wątroby w połączeniu z drugim agentem bez oporności krzyżowej do ламивудину.

Triumeq Unia Europejska - polski - EMA (European Medicines Agency)

triumeq

viiv healthcare b.v. - dolutegravir sodium, lamivudine, abacavir (as sulfate) - infekcje hiv - Środki przeciwwirusowe do użytku ogólnoustrojowego - triumeq is indicated for the treatment of human immunodeficiency virus (hiv) infected adults,  adolescents and children  weighing at least 25 kg who are antiretroviral treatment-naïve or are infected with hiv without documented or clinically suspected resistance to any of the three antiretroviral agents in triumeq.

Flebogamma DIF (previously Flebogammadif) Unia Europejska - polski - EMA (European Medicines Agency)

flebogamma dif (previously flebogammadif)

instituto grifols s.a. - immunoglobuliny ludzkiej normalnej - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - odporne surowicy i immunoglobuliny, - 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.

Rayvow Unia Europejska - polski - EMA (European Medicines Agency)

rayvow

eli lilly nederland b.v. - lasmiditan succinate - choroby migreny - Środki przeciwbólowe - rayvow is indicated for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.

Retsevmo Unia Europejska - polski - EMA (European Medicines Agency)

retsevmo

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - Środki przeciwnowotworowe - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

Briumvi Unia Europejska - polski - EMA (European Medicines Agency)

briumvi

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - leki immunosupresyjne - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Icatibant Accord Unia Europejska - polski - EMA (European Medicines Agency)

icatibant accord

accord healthcare s.l.u. - icatibant acetate - angioedemas, dziedziczny - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.