SFDA-2023-0057-V357

Type II variation for application SFDA-2023-0057. Type II variation: Labeling Change for Lecanemabix — routine update

Variation Number
SFDA-2023-0057-V357
Type
Type II
Application
SFDA-2023-0057
Change
CHG-2024-0057
Status
Failed
Fee
€13,836
Submitted
2023-02-12
Approved
—
Description

Type II variation: Labeling Change for Lecanemabix — routine update