CHG-2022-0043
Specification Change for Tiotropizone. New Dosage Strength for Tiotropizone — critical change. Impacts 8 markets and 5 variations.
Change Number
CHG-2022-0043
Type
Specification Change
Product
Status
Pending
Owner
Dmitri Volkov
Initiated
2022-07-10
Description
New Dosage Strength for Tiotropizone — critical change
Impacted Markets (8)
US — United StatesCH — SwitzerlandIT — ItalyAR — ArgentinaTR — TurkeySE — SwedenBE — BelgiumPT — Portugal
Impacted Modules
3.2.S5.3.53.2.P.34.2.1
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0011-V211 | Type II | TFDA-2024-0011 | Failed | 2022-09-06 | — |
| HSA-2023-0012-V212 | Type IA | HSA-2023-0012 | Submitted | — | — |
| CDSCO-2022-0013-V213 | Type II | CDSCO-2022-0013 | Pending | 2022-09-30 | — |
| COFEPRIS-2021-0014-V214 | Major | COFEPRIS-2021-0014 | Approved | 2023-09-24 | 2024-03-03 |
| ANMAT-2020-0015-V215 | Type IA | ANMAT-2020-0015 | Blocked | — | — |