CHG-2021-0096
Manufacturing Process Change for Dupitumacon. Formulation Change for Dupitumacon — routine update. Impacts 7 markets and 2 variations.
Change Number
CHG-2021-0096
Type
Manufacturing Process Change
Product
Status
Blocked
Owner
Nadia Petrova
Initiated
2023-12-16
Description
Formulation Change for Dupitumacon — routine update
Impacted Markets (7)
JP — JapanBR — BrazilFR — FranceES — SpainNL — NetherlandsKR — South KoreaBE — Belgium
Impacted Modules
3.2.P3.2.P.3
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TITCK-2024-0076-V476 | Major | TITCK-2024-0076 | Approved | 2023-03-29 | 2023-11-09 |
| SFDA-2023-0077-V477 | Type II | SFDA-2023-0077 | Approved | — | 2023-09-30 |