CHG-2023-0074
Manufacturing Process Change for Glucovantib. Formulation Change for Glucovantib — routine update. Impacts 8 markets and 4 variations.
Change Number
CHG-2023-0074
Type
Manufacturing Process Change
Product
Status
In Progress
Owner
James O'Brien
Initiated
2022-05-19
Description
Formulation Change for Glucovantib — routine update
Impacted Markets (8)
US — United StatesCN — ChinaCA — CanadaIT — ItalyNL — NetherlandsTR — TurkeySE — SwedenAT — Austria
Impacted Modules
5.3.52.3.P4.2.13.2.P.3
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0066-V366 | Type II | HC-2024-0066 | Pending | 2024-02-25 | — |
| TGA-2023-0067-V367 | Type II | TGA-2023-0067 | Completed | 2023-05-03 | — |
| MHRA-2022-0068-V368 | Minor | MHRA-2022-0068 | Blocked | 2023-06-01 | — |
| SwissMedic-2021-0069-V369 | Type II | SwissMedic-2021-0069 | Submitted | — | — |