CHG-2022-0095
Facility Change for Immunovant-α. Shelf Life Extension for Immunovant-α — minor update. Impacts 7 markets and 4 variations.
Change Number
CHG-2022-0095
Type
Facility Change
Product
Status
Submitted
Owner
James O'Brien
Initiated
2022-11-12
Description
Shelf Life Extension for Immunovant-α — minor update
Impacted Markets (7)
CN — ChinaBR — BrazilES — SpainKR — South KoreaSG — SingaporeSE — SwedenBE — Belgium
Impacted Modules
2.3.P
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0071-V471 | Type IB | TFDA-2024-0071 | Submitted | 2024-01-14 | — |
| HSA-2023-0072-V472 | Type IA | HSA-2023-0072 | Blocked | — | — |
| CDSCO-2022-0073-V473 | Major | CDSCO-2022-0073 | Completed | — | — |
| COFEPRIS-2021-0074-V474 | Minor | COFEPRIS-2021-0074 | Failed | — | — |