CHG-2023-0014

Formulation Change for Glucovantib. New Dosage Strength for Glucovantib — major revision. Impacts 4 markets and 2 variations.

Change Number
CHG-2023-0014
Type
Formulation Change
Product
Glucovantib
Status
Active
Owner
James O'Brien
Initiated
2022-08-28
Description

New Dosage Strength for Glucovantib — major revision

Impacted Markets (4)
CA — CanadaGB — United KingdomMX — MexicoSA — Saudi Arabia
Impacted Modules
4.2.12.3.P
Linked Variations (2)
Variation #TypeApplicationStatusSubmittedApproved
HC-2024-0066-V066Type IBHC-2024-0066Active2022-12-31—
TGA-2023-0067-V067Type IBTGA-2023-0067Failed2024-06-02—