CHG-2023-0030

Manufacturing Process Change for Mavacamtamex. Analytical Method Change for Mavacamtamex — routine update. Impacts 2 markets and 5 variations.

Change Number
CHG-2023-0030
Type
Manufacturing Process Change
Product
Mavacamtamex
Status
Approved
Owner
Sarah Chen
Initiated
2023-12-14
Description

Analytical Method Change for Mavacamtamex — routine update

Impacted Markets (2)
JP — JapanSE — Sweden
Impacted Modules
5.3.5
Linked Variations (5)
Variation #TypeApplicationStatusSubmittedApproved
HC-2024-0046-V146Type IBHC-2024-0046Failed——
TGA-2023-0047-V147Type IITGA-2023-0047Pending2023-09-11—
MHRA-2022-0048-V148Type IIMHRA-2022-0048Approved2024-04-282023-09-03
SwissMedic-2021-0049-V149Type IBSwissMedic-2021-0049Submitted——
MFDS-2020-0050-V150Type IAMFDS-2020-0050Draft2022-08-28—