CHG-2024-0033
Formulation Change for Cardilostat. New Dosage Strength for Cardilostat — major revision. Impacts 7 markets and 5 variations.
Change Number
CHG-2024-0033
Type
Formulation Change
Product
Status
Active
Owner
Carlos Mendez
Initiated
2022-12-19
Description
New Dosage Strength for Cardilostat — major revision
Impacted Markets (7)
EU — European UnionAU — AustraliaMX — MexicoAR — ArgentinaZA — South AfricaAT — AustriaPT — Portugal
Impacted Modules
3.2.P4.2.15.3.53.2.S
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0061-V161 | Type IB | FDA-2024-0061 | Pending | 2023-06-10 | — |
| EMA-2023-0062-V162 | Major | EMA-2023-0062 | Pending | 2024-03-11 | — |
| PMDA-2022-0063-V163 | Major | PMDA-2022-0063 | Active | 2023-03-25 | — |
| NMPA-2021-0064-V164 | Type IA | NMPA-2021-0064 | Completed | 2022-10-27 | — |
| ANVISA-2020-0065-V165 | Major | ANVISA-2020-0065 | Approved | — | 2024-05-16 |