CHG-2023-0022
Labeling Change for Sacubitrivex. Storage Condition Change for Sacubitrivex — critical change. Impacts 7 markets and 2 variations.
Change Number
CHG-2023-0022
Type
Labeling Change
Product
Status
Approved
Owner
Aisha Okonkwo
Initiated
2023-03-28
Description
Storage Condition Change for Sacubitrivex — critical change
Impacted Markets (7)
US — United StatesJP — JapanCA — CanadaKR — South KoreaPL — PolandSE — SwedenBE — Belgium
Impacted Modules
2.3.P3.2.P.3
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0006-V106 | Type IA | HC-2024-0006 | Submitted | 2023-11-20 | — |
| TGA-2023-0007-V107 | Major | TGA-2023-0007 | In Progress | — | — |