CHG-2024-0025
Shelf Life Extension for Tisagenlecleux-B. Analytical Method Change for Tisagenlecleux-B — minor update. Impacts 6 markets and 2 variations.
Change Number
CHG-2024-0025
Type
Shelf Life Extension
Product
Status
Draft
Owner
Tomoko Ikeda
Initiated
2022-02-12
Description
Analytical Method Change for Tisagenlecleux-B — minor update
Impacted Markets (6)
US — United StatesBR — BrazilGB — United KingdomTW — TaiwanSA — Saudi ArabiaPT — Portugal
Impacted Modules
3.2.S4.2.15.3.5
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0021-V121 | Type IA | FDA-2024-0021 | Approved | — | 2023-12-23 |
| EMA-2023-0022-V122 | Type IB | EMA-2023-0022 | Failed | 2023-01-30 | — |