CHG-2022-0003
Specification Change for Cardilostat. Analytical Method Change for Cardilostat — routine update. Impacts 8 markets and 4 variations.
Change Number
CHG-2022-0003
Type
Specification Change
Product
Status
Pending
Owner
Dmitri Volkov
Initiated
2022-05-29
Description
Analytical Method Change for Cardilostat — routine update
Impacted Markets (8)
CN — ChinaBR — BrazilCH — SwitzerlandDE — GermanyIN — IndiaPL — PolandBE — BelgiumAT — Austria
Impacted Modules
2.3.P
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0011-V011 | Type IB | TFDA-2024-0011 | Approved | — | 2024-03-29 |
| HSA-2023-0012-V012 | Type IA | HSA-2023-0012 | Overdue | — | — |
| CDSCO-2022-0013-V013 | Type II | CDSCO-2022-0013 | Overdue | — | — |
| COFEPRIS-2021-0014-V014 | Type IB | COFEPRIS-2021-0014 | Completed | 2023-11-24 | — |