CHG-2023-0050
Labeling Change for Erenumabix. New Dosage Strength for Erenumabix — major revision. Impacts 5 markets and 4 variations.
Change Number
CHG-2023-0050
Type
Labeling Change
Product
Status
Failed
Owner
Aisha Okonkwo
Initiated
2023-09-09
Description
New Dosage Strength for Erenumabix — major revision
Impacted Markets (5)
CA — CanadaCH — SwitzerlandIT — ItalyIN — IndiaPL — Poland
Impacted Modules
5.3.53.2.S3.2.P.34.2.1
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0046-V246 | Major | HC-2024-0046 | Completed | — | — |
| TGA-2023-0047-V247 | Minor | TGA-2023-0047 | In Progress | 2022-09-03 | — |
| MHRA-2022-0048-V248 | Minor | MHRA-2022-0048 | Pending | — | — |
| SwissMedic-2021-0049-V249 | Type II | SwissMedic-2021-0049 | Active | — | — |