Nebenwirkungen · Remsima
Remsima 120 mg solution for injection in pre-filled syringe Remsima 120 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 56
HOS-127229 · Präparat HOS-096377
In the integrated analysis including a Phase I study conducted in patients with active Crohn’s disease and active ulcerative colitis, a Phase III study conducted in patients with active Crohn’s disease and a Phase III study conducted in patients with active ulcerative colitis, the safety population consisted of 631 patients in the Remsima subcutaneous group (297 patients with active Crohn’s disease and 334 patients with active ulcerative colitis) and 245 patients in the Placebo group (105 patients with active Crohn’s disease and 140 patients with active ulcerative colitis). For study details, see Section 5.1.
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Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
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