CHG-2022-0039
Facility Change for Raredimab. Storage Condition Change for Raredimab — routine update. Impacts 7 markets and 5 variations.
Change Number
CHG-2022-0039
Type
Facility Change
Product
Status
Failed
Owner
Aisha Okonkwo
Initiated
2022-09-30
Description
Storage Condition Change for Raredimab — routine update
Impacted Markets (7)
US — United StatesBR — BrazilAU — AustraliaKR — South KoreaIN — IndiaZA — South AfricaRU — Russia
Impacted Modules
3.2.P2.3.P4.2.13.2.S
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0091-V191 | Type IB | TFDA-2024-0091 | Completed | — | — |
| HSA-2023-0092-V192 | Major | HSA-2023-0092 | Failed | 2023-09-15 | — |
| CDSCO-2022-0093-V193 | Minor | CDSCO-2022-0093 | Approved | 2023-12-16 | 2024-06-06 |
| COFEPRIS-2021-0094-V194 | Minor | COFEPRIS-2021-0094 | Draft | 2022-08-14 | — |
| ANMAT-2020-0095-V195 | Major | ANMAT-2020-0095 | Pending | 2023-01-03 | — |