CHG-2024-0057
Specification Change for Lecanemabix. Labeling Change for Lecanemabix — routine update. Impacts 1 markets and 4 variations.
Change Number
CHG-2024-0057
Type
Specification Change
Product
Status
Completed
Owner
Lieselotte van der Berg
Initiated
2023-08-05
Description
Labeling Change for Lecanemabix — routine update
Impacted Markets (1)
IT — Italy
Impacted Modules
3.2.P.35.3.54.2.1
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0081-V281 | Minor | FDA-2024-0081 | Completed | — | — |
| EMA-2023-0082-V282 | Type II | EMA-2023-0082 | Blocked | — | — |
| PMDA-2022-0083-V283 | Type IA | PMDA-2022-0083 | Approved | — | 2024-05-22 |
| NMPA-2021-0084-V284 | Type IB | NMPA-2021-0084 | Submitted | 2022-11-21 | — |