300 mg/ 3 mL
Trade Name
Ultomiris
Concentrate for Solution for Infusion
Request Type
New Registration
Drug Type
Biological
Approval Date
SFDA Approved Use
Ravulizumab is indicated for:
•The treatment of adult and pediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal hemoglobinuria (PNH).
•The treatment of adults and pediatric patients with a body weight of 10 kg or above with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
•The treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
•The treatment of adult patients with anti-aquaporin 4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).
•The treatment of adult and pediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal hemoglobinuria (PNH).
•The treatment of adults and pediatric patients with a body weight of 10 kg or above with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
•The treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
•The treatment of adult patients with anti-aquaporin 4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).