CHG-2021-0064
Labeling Change for Neprilozone. Labeling Change for Neprilozone — minor update. Impacts 6 markets and 3 variations.
Change Number
CHG-2021-0064
Type
Labeling Change
Product
Status
In Progress
Owner
Nadia Petrova
Initiated
2022-12-20
Description
Labeling Change for Neprilozone — minor update
Impacted Markets (6)
US — United StatesAU — AustraliaES — SpainSG — SingaporeRU — RussiaPL — Poland
Impacted Modules
2.3.P
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TITCK-2024-0016-V316 | Major | TITCK-2024-0016 | Approved | 2022-11-18 | 2024-06-24 |
| SFDA-2023-0017-V317 | Type II | SFDA-2023-0017 | Draft | 2023-01-01 | — |
| SAHPRA-2022-0018-V318 | Minor | SAHPRA-2022-0018 | Submitted | — | — |