CHG-2022-0035
Formulation Change for Immunovant-α. Facility Change for Immunovant-α — critical change. Impacts 6 markets and 2 variations.
Change Number
CHG-2022-0035
Type
Formulation Change
Product
Status
Submitted
Owner
Marcus Webb
Initiated
2022-12-24
Description
Facility Change for Immunovant-α — critical change
Impacted Markets (6)
US — United StatesEU — European UnionCN — ChinaFR — FranceES — SpainAR — Argentina
Impacted Modules
5.3.53.2.P
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0071-V171 | Minor | TFDA-2024-0071 | Draft | — | — |
| HSA-2023-0072-V172 | Type IA | HSA-2023-0072 | In Progress | 2022-08-21 | — |