CHG-2023-0034
Analytical Method Change for Neprilozone. Shelf Life Extension for Neprilozone — major revision. Impacts 3 markets and 3 variations.
Change Number
CHG-2023-0034
Type
Analytical Method Change
Product
Status
Overdue
Owner
James O'Brien
Initiated
2022-06-14
Description
Shelf Life Extension for Neprilozone — major revision
Impacted Markets (3)
IT — ItalyIN — IndiaSE — Sweden
Impacted Modules
2.3.P4.2.1
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0066-V166 | Type IA | HC-2024-0066 | Failed | — | — |
| TGA-2023-0067-V167 | Type IA | TGA-2023-0067 | Blocked | 2022-09-10 | — |
| MHRA-2022-0068-V168 | Type II | MHRA-2022-0068 | Draft | 2023-05-29 | — |