CHG-2022-0063

Formulation Change for Cardilostat. Labeling Change for Cardilostat — minor update. Impacts 5 markets and 4 variations.

Change Number
CHG-2022-0063
Type
Formulation Change
Product
Cardilostat
Status
Draft
Owner
Sarah Chen
Initiated
2023-02-10
Description

Labeling Change for Cardilostat — minor update

Impacted Markets (5)
CN — ChinaBR — BrazilCA — CanadaMX — MexicoAR — Argentina
Impacted Modules
3.2.P2.3.P3.2.P.3
Linked Variations (4)
Variation #TypeApplicationStatusSubmittedApproved
TFDA-2024-0011-V311Type IATFDA-2024-0011Pending2022-08-24—
HSA-2023-0012-V312Type IBHSA-2023-0012In Progress2023-12-09—
CDSCO-2022-0013-V313MinorCDSCO-2022-0013In Progress2023-06-26—
COFEPRIS-2021-0014-V314Type IACOFEPRIS-2021-0014In Progress2023-05-18—