CHG-2023-0054
Container Closure Change for Semaglutidex. Formulation Change for Semaglutidex — minor update. Impacts 8 markets and 5 variations.
Change Number
CHG-2023-0054
Type
Container Closure Change
Product
Status
Overdue
Owner
Lieselotte van der Berg
Initiated
2022-02-23
Description
Formulation Change for Semaglutidex — minor update
Impacted Markets (8)
BR — BrazilGB — United KingdomIT — ItalyNL — NetherlandsAR — ArgentinaZA — South AfricaSE — SwedenDK — Denmark
Impacted Modules
3.2.P.3
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0066-V266 | Minor | HC-2024-0066 | Overdue | — | — |
| TGA-2023-0067-V267 | Major | TGA-2023-0067 | Active | 2023-07-03 | — |
| MHRA-2022-0068-V268 | Type IA | MHRA-2022-0068 | Overdue | — | — |
| SwissMedic-2021-0069-V269 | Major | SwissMedic-2021-0069 | Approved | — | 2024-04-10 |
| MFDS-2020-0070-V270 | Type IB | MFDS-2020-0070 | Failed | 2023-01-01 | — |