Labeling Change for Immunovant-α. Analytical Method Change for Immunovant-α — critical change. Impacts 8 markets and 2 variations.

Change Number
CHG-2024-0245
Type
Labeling Change
Status
Draft
Owner
James O'Brien
Initiated
2022-08-24
Description

Analytical Method Change for Immunovant-α — critical change

Impacted Markets (8)
JP — JapanAU — AustraliaCH — SwitzerlandNL — NetherlandsIN — IndiaRU — RussiaPT — PortugalDK — Denmark
Impacted Modules
3.2.P.33.2.S
Linked Variations (0)
Variation #TypeApplicationStatusSubmittedApproved