CHG-2024-0069
Analytical Method Change for Raredimab. Storage Condition Change for Raredimab — minor update. Impacts 4 markets and 3 variations.
Change Number
CHG-2024-0069
Type
Analytical Method Change
Product
Status
Submitted
Owner
James O'Brien
Initiated
2022-01-14
Description
Storage Condition Change for Raredimab — minor update
Impacted Markets (4)
GB — United KingdomDE — GermanyIT — ItalyAR — Argentina
Impacted Modules
5.3.54.2.12.3.P
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0041-V341 | Type II | FDA-2024-0041 | Approved | 2024-01-07 | 2023-09-25 |
| EMA-2023-0042-V342 | Type IB | EMA-2023-0042 | Submitted | — | — |
| PMDA-2022-0043-V343 | Type IA | PMDA-2022-0043 | In Progress | — | — |