Nebenwirkungen · Usgena
Usgena 45 mg solution for injection Usgena 45 mg solution for injection in pre-filled syringe Usgena 90 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 30
HOS-153971 · Präparat HOS-101078
The safety data described below reflect exposure in adults to ustekinumab in 14 phase 2 and phase 3 studies in 6,710 patients (4,135 with psoriasis and/or psoriatic arthritis, 1,749 with Crohn’s disease and 826 patients with ulcerative colitis). This includes exposure to ustekinumab in the controlled and non-controlled periods of the clinical studies in patients with psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis for at least 6 months (4,577 patients) or at least 1 year (3,648 patients). 2,194 patients with psoriasis, Crohn’s disease or ulcerative colitis for at least 4 years while 1,148 patients with psoriasis or Crohn’s disease were exposed for at least 5 years.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-08-11T11:11:01Z · SHA-256 8e5be544de91a74438b6084c7497550446fa3104ba8f5e5368034aaef5a300fc · Passage c6eddd1fa243d276cc201d4b7d35a34d445f24008afed062ae178c4b4e880e62 · Zeichen 658–1353 im Abschnitt