CHG-2022-0099
Container Closure Change for Raredimab. Labeling Change for Raredimab — minor update. Impacts 5 markets and 1 variations.
Change Number
CHG-2022-0099
Type
Container Closure Change
Product
Status
Blocked
Owner
Carlos Mendez
Initiated
2023-01-08
Description
Labeling Change for Raredimab — minor update
Impacted Markets (5)
US — United StatesBR — BrazilNL — NetherlandsSG — SingaporeRU — Russia
Impacted Modules
2.3.P3.2.P.33.2.P
Linked Variations (1)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0091-V491 | Type II | TFDA-2024-0091 | Pending | 2023-01-11 | — |