Union européenne - tchèque - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - avacopan - microscopic polyangiitis; wegener granulomatosis - imunosupresiva - tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa).

Union européenne - tchèque - EMA (European Medicines Agency)

laboratorios farmacéuticos rovi, s.a. - risperidone - schizofrenie - psycholeptika - treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.

Union européenne - tchèque - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - imunosupresiva - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

Union européenne - tchèque - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - mnohočetný myelom - antineoplastická činidla - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Union européenne - tchèque - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ekulizumab - hemoglobinurie, paroxysmální - imunosupresiva - epysqli is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

Union européenne - tchèque - EMA (European Medicines Agency)

amgen technology (ireland) uc - ekulizumab - hemoglobinurie, paroxysmální - imunosupresiva - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). důkazy o klinické prospěšnosti je prokázána u pacientů s hemolýza s klinickým příznakem(s) svědčí o vysoké aktivity nemoci, bez ohledu na to, transfúze historie (viz bod 5.

République tchèque - tchèque - SUKL (Státní ústav pro kontrolu léčiv)

leo pharma a/s, ballerup array - 9339 methylprednisolon-aceponÁt - krém - 1mg/g - methylprednisolon-aceponÁt

République tchèque - tchèque - SUKL (Státní ústav pro kontrolu léčiv)

leo pharma a/s, ballerup array - 9339 methylprednisolon-aceponÁt - krém - 1mg/g - methylprednisolon-aceponÁt

République tchèque - tchèque - SUKL (Státní ústav pro kontrolu léčiv)

ebewe pharma ges.m.b.h nfg.kg, unterach array - 1570 cytarabin - koncentrát pro infuzní roztok - 50mg/ml - cytarabin

République tchèque - tchèque - SUKL (Státní ústav pro kontrolu léčiv)

mylan ireland limited, dublin array - 10264 dihydrÁt azithromycinu - potahovaná tableta - 500mg - azithromycin