CHG-2023-0042
Storage Condition Change for Respiralimab. Labeling Change for Respiralimab — routine update. Impacts 1 markets and 3 variations.
Change Number
CHG-2023-0042
Type
Storage Condition Change
Product
Status
Draft
Owner
James O'Brien
Initiated
2022-08-16
Description
Labeling Change for Respiralimab — routine update
Impacted Markets (1)
BR — Brazil
Impacted Modules
2.3.P3.2.P.35.3.5
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0006-V206 | Type IB | HC-2024-0006 | Overdue | — | — |
| TGA-2023-0007-V207 | Minor | TGA-2023-0007 | Failed | 2022-07-30 | — |
| MHRA-2022-0008-V208 | Major | MHRA-2022-0008 | Pending | 2023-01-04 | — |