CHG-2021-0004
Shelf Life Extension for Neprilozone. Formulation Change for Neprilozone — major revision. Impacts 3 markets and 3 variations.
Change Number
CHG-2021-0004
Type
Shelf Life Extension
Product
Status
Draft
Owner
Lieselotte van der Berg
Initiated
2022-08-01
Description
Formulation Change for Neprilozone — major revision
Impacted Markets (3)
US — United StatesSE — SwedenDK — Denmark
Impacted Modules
2.3.P3.2.S3.2.P.3
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TITCK-2024-0016-V016 | Type IB | TITCK-2024-0016 | Draft | — | — |
| SFDA-2023-0017-V017 | Type IA | SFDA-2023-0017 | Active | — | — |
| SAHPRA-2022-0018-V018 | Minor | SAHPRA-2022-0018 | Approved | 2024-02-23 | 2023-11-06 |