CHG-2021-0024
Formulation Change for Semaglutidex. New Dosage Strength for Semaglutidex — major revision. Impacts 3 markets and 2 variations.
Change Number
CHG-2021-0024
Type
Formulation Change
Product
Status
Overdue
Owner
Sarah Chen
Initiated
2023-03-02
Description
New Dosage Strength for Semaglutidex — major revision
Impacted Markets (3)
BR — BrazilSA — Saudi ArabiaZA — South Africa
Impacted Modules
3.2.S
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TITCK-2024-0016-V116 | Type IA | TITCK-2024-0016 | Active | 2022-12-06 | — |
| SFDA-2023-0017-V117 | Major | SFDA-2023-0017 | Approved | 2024-05-14 | 2024-03-26 |