CHG-2023-0006

Specification Change for Dupitumacon. New Dosage Strength for Dupitumacon — major revision. Impacts 8 markets and 5 variations.

Change Number
CHG-2023-0006
Type
Specification Change
Product
Dupitumacon
Status
Failed
Owner
Sarah Chen
Initiated
2022-03-31
Description

New Dosage Strength for Dupitumacon — major revision

Impacted Markets (8)
US — United StatesEU — European UnionCA — CanadaGB — United KingdomES — SpainMX — MexicoAR — ArgentinaTR — Turkey
Impacted Modules
5.3.53.2.P.34.2.13.2.P
Linked Variations (5)
Variation #TypeApplicationStatusSubmittedApproved
HC-2024-0026-V026Type IAHC-2024-0026Blocked2024-02-05—
TGA-2023-0027-V027Type IATGA-2023-0027Active——
MHRA-2022-0028-V028MinorMHRA-2022-0028Submitted2024-05-28—
SwissMedic-2021-0029-V029Type IISwissMedic-2021-0029Failed2022-08-18—
MFDS-2020-0030-V030Type IIMFDS-2020-0030Completed2023-04-04—