CHG-2023-0018
Storage Condition Change for Pancrelipaze-R. Formulation Change for Pancrelipaze-R — critical change. Impacts 8 markets and 5 variations.
Change Number
CHG-2023-0018
Type
Storage Condition Change
Product
Status
Draft
Owner
Priya Sharma
Initiated
2022-12-22
Description
Formulation Change for Pancrelipaze-R — critical change
Impacted Markets (8)
BR — BrazilCA — CanadaAU — AustraliaGB — United KingdomTW — TaiwanSG — SingaporeBE — BelgiumPT — Portugal
Impacted Modules
3.2.P3.2.S3.2.P.34.2.1
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0086-V086 | Major | HC-2024-0086 | Submitted | 2023-09-19 | — |
| TGA-2023-0087-V087 | Type IB | TGA-2023-0087 | Active | 2022-09-30 | — |
| MHRA-2022-0088-V088 | Type II | MHRA-2022-0088 | Blocked | — | — |
| SwissMedic-2021-0089-V089 | Type II | SwissMedic-2021-0089 | Blocked | 2023-04-16 | — |
| MFDS-2020-0090-V090 | Minor | MFDS-2020-0090 | Pending | 2023-08-20 | — |