CHG-2022-0007
Facility Change for Neuravastatin. Specification Change for Neuravastatin — major revision. Impacts 7 markets and 4 variations.
Change Number
CHG-2022-0007
Type
Facility Change
Product
Status
Failed
Owner
Priya Sharma
Initiated
2023-09-22
Description
Specification Change for Neuravastatin — major revision
Impacted Markets (7)
CN — ChinaGB — United KingdomIT — ItalyES — SpainKR — South KoreaIN — IndiaAR — Argentina
Impacted Modules
2.3.P3.2.S4.2.1
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0031-V031 | Major | TFDA-2024-0031 | Completed | 2023-06-16 | — |
| HSA-2023-0032-V032 | Type II | HSA-2023-0032 | Draft | — | — |
| CDSCO-2022-0033-V033 | Major | CDSCO-2022-0033 | In Progress | 2023-10-01 | — |
| COFEPRIS-2021-0034-V034 | Minor | COFEPRIS-2021-0034 | Overdue | 2024-02-28 | — |