CHG-2024-0065
Storage Condition Change for Immunovant-α. Formulation Change for Immunovant-α — routine update. Impacts 2 markets and 4 variations.
Change Number
CHG-2024-0065
Type
Storage Condition Change
Product
Status
Completed
Owner
Sarah Chen
Initiated
2023-11-24
Description
Formulation Change for Immunovant-α — routine update
Impacted Markets (2)
KR — South KoreaSE — Sweden
Impacted Modules
3.2.S
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0021-V321 | Minor | FDA-2024-0021 | Active | — | — |
| EMA-2023-0022-V322 | Minor | EMA-2023-0022 | In Progress | 2023-11-24 | — |
| PMDA-2022-0023-V323 | Major | PMDA-2022-0023 | Active | 2022-08-31 | — |
| NMPA-2021-0024-V324 | Type II | NMPA-2021-0024 | Pending | 2023-12-14 | — |