CHG-2024-0093

Shelf Life Extension for Cardilostat. Manufacturing Process Change for Cardilostat — major revision. Impacts 4 markets and 3 variations.

Change Number
CHG-2024-0093
Type
Shelf Life Extension
Product
Cardilostat
Status
Blocked
Owner
Carlos Mendez
Initiated
2022-07-20
Description

Manufacturing Process Change for Cardilostat — major revision

Impacted Markets (4)
BR — BrazilAU — AustraliaDE — GermanyIT — Italy
Impacted Modules
2.3.P
Linked Variations (3)
Variation #TypeApplicationStatusSubmittedApproved
FDA-2024-0061-V461Type IAFDA-2024-0061Active2024-02-09—
EMA-2023-0062-V462Type IAEMA-2023-0062Pending2022-08-02—
PMDA-2022-0063-V463Type IIPMDA-2022-0063Approved2023-01-162024-03-23