Roche Diagnostics GmbH (Manufacturing of medicinal product (including filling/primary packaging), in-process control testing, quality control testing at release and stability)

The drug is indicated for the treatment of adults and children aged 12 years and older (weighing 40 kg or more) with paroxysmal nocturnal hemoglobinuria (PNH). It is used both during active hemolysis and for patients who have stabilized after treatment with other C5 component inhibitors.

Dosage form: solution for injection or infusion

ATC: L04AJ07