CHG-2021-0044

Container Closure Change for Glucovantib. Storage Condition Change for Glucovantib — routine update. Impacts 8 markets and 5 variations.

Change Number
CHG-2021-0044
Type
Container Closure Change
Product
Glucovantib
Status
Approved
Owner
Marcus Webb
Initiated
2022-11-19
Description

Storage Condition Change for Glucovantib — routine update

Impacted Markets (8)
US — United StatesCA — CanadaGB — United KingdomTW — TaiwanMX — MexicoTR — TurkeyPL — PolandSE — Sweden
Impacted Modules
3.2.S3.2.P.3
Linked Variations (5)
Variation #TypeApplicationStatusSubmittedApproved
TITCK-2024-0016-V216Type IATITCK-2024-0016Overdue2023-01-26—
SFDA-2023-0017-V217MinorSFDA-2023-0017Submitted2023-12-14—
SAHPRA-2022-0018-V218Type IISAHPRA-2022-0018In Progress2024-01-19—
Roszdravnadzor-2021-0019-V219MinorRoszdravnadzor-2021-0019In Progress——
MOH-IL-2020-0020-V220MajorMOH-IL-2020-0020Approved2023-06-282024-05-21