CHG-2022-0087
Specification Change for Lecanemabix. Shelf Life Extension for Lecanemabix — major revision. Impacts 4 markets and 4 variations.
Change Number
CHG-2022-0087
Type
Specification Change
Product
Status
Overdue
Owner
Dmitri Volkov
Initiated
2023-12-13
Description
Shelf Life Extension for Lecanemabix — major revision
Impacted Markets (4)
CN — ChinaIT — ItalySG — SingaporeDK — Denmark
Impacted Modules
3.2.S3.2.P.35.3.5
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0031-V431 | Type II | TFDA-2024-0031 | Completed | — | — |
| HSA-2023-0032-V432 | Minor | HSA-2023-0032 | Active | — | — |
| CDSCO-2022-0033-V433 | Type II | CDSCO-2022-0033 | Draft | 2024-02-21 | — |
| COFEPRIS-2021-0034-V434 | Major | COFEPRIS-2021-0034 | Overdue | 2024-05-30 | — |