CHG-2024-0073
Storage Condition Change for Tiotropizone. Analytical Method Change for Tiotropizone — routine update. Impacts 4 markets and 3 variations.
Change Number
CHG-2024-0073
Type
Storage Condition Change
Product
Status
Blocked
Owner
Dmitri Volkov
Initiated
2022-04-03
Description
Analytical Method Change for Tiotropizone — routine update
Impacted Markets (4)
BR — BrazilIN — IndiaMX — MexicoAT — Austria
Impacted Modules
2.3.P5.3.53.2.P
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0061-V361 | Major | FDA-2024-0061 | Failed | — | — |
| EMA-2023-0062-V362 | Major | EMA-2023-0062 | Approved | 2024-05-24 | 2024-03-08 |
| PMDA-2022-0063-V363 | Major | PMDA-2022-0063 | Active | 2024-03-22 | — |