CHG-2024-0005
Shelf Life Extension for Immunovant-α. Container Closure Change for Immunovant-α — routine update. Impacts 7 markets and 5 variations.
Change Number
CHG-2024-0005
Type
Shelf Life Extension
Product
Status
Draft
Owner
Nadia Petrova
Initiated
2022-07-19
Description
Container Closure Change for Immunovant-α — routine update
Impacted Markets (7)
CH — SwitzerlandDE — GermanyTW — TaiwanIN — IndiaMX — MexicoAR — ArgentinaRU — Russia
Impacted Modules
3.2.P.3
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0021-V021 | Minor | FDA-2024-0021 | Failed | 2022-08-29 | — |
| EMA-2023-0022-V022 | Type II | EMA-2023-0022 | Submitted | 2023-12-08 | — |
| PMDA-2022-0023-V023 | Minor | PMDA-2022-0023 | Pending | 2023-02-05 | — |
| NMPA-2021-0024-V024 | Major | NMPA-2021-0024 | Failed | — | — |
| ANVISA-2020-0025-V025 | Type IA | ANVISA-2020-0025 | In Progress | — | — |