CHG-2023-0094
Facility Change for Neprilozone. New Dosage Strength for Neprilozone — critical change. Impacts 2 markets and 3 variations.
Change Number
CHG-2023-0094
Type
Facility Change
Product
Status
Submitted
Owner
Tomoko Ikeda
Initiated
2022-03-07
Description
New Dosage Strength for Neprilozone — critical change
Impacted Markets (2)
ZA — South AfricaSE — Sweden
Impacted Modules
3.2.P.3
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0066-V466 | Type IA | HC-2024-0066 | Approved | 2023-05-15 | 2024-05-28 |
| TGA-2023-0067-V467 | Minor | TGA-2023-0067 | Failed | — | — |
| MHRA-2022-0068-V468 | Type IA | MHRA-2022-0068 | Approved | — | 2024-01-17 |