Labeling Change for Lecanemabix. Storage Condition Change for Lecanemabix — critical change. Impacts 6 markets and 1 variations.

Change Number
CHG-2022-0027
Type
Labeling Change
Status
In Progress
Owner
Carlos Mendez
Initiated
2022-03-04
Description

Storage Condition Change for Lecanemabix — critical change

Impacted Markets (6)
JP — JapanCH — SwitzerlandIN — IndiaAR — ArgentinaSE — SwedenPT — Portugal
Impacted Modules
2.3.P3.2.S
Linked Variations (1)
Variation #TypeApplicationStatusSubmittedApproved
TFDA-2024-0031-V131MinorTFDA-2024-0031Pending2023-09-08—