CHG-2023-0086
Facility Change for Ozanemolistat. Formulation Change for Ozanemolistat — critical change. Impacts 4 markets and 3 variations.
Change Number
CHG-2023-0086
Type
Facility Change
Product
Status
Completed
Owner
Dmitri Volkov
Initiated
2022-09-02
Description
Formulation Change for Ozanemolistat — critical change
Impacted Markets (4)
MX — MexicoSA — Saudi ArabiaAT — AustriaDK — Denmark
Impacted Modules
3.2.P.3
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0026-V426 | Type II | HC-2024-0026 | In Progress | — | — |
| TGA-2023-0027-V427 | Minor | TGA-2023-0027 | In Progress | 2023-08-03 | — |
| MHRA-2022-0028-V428 | Type IB | MHRA-2022-0028 | Active | — | — |