Specification Change for Lorlatenilib. New Dosage Strength for Lorlatenilib — major revision. Impacts 8 markets and 2 variations.

Change Number
CHG-2022-0231
Type
Specification Change
Status
Approved
Owner
Tomoko Ikeda
Initiated
2023-09-19
Description

New Dosage Strength for Lorlatenilib — major revision

Impacted Markets (8)
EU — European UnionCN — ChinaIT — ItalySG — SingaporeIN — IndiaMX — MexicoSE — SwedenAT — Austria
Impacted Modules
4.2.12.3.P
Linked Variations (0)
Variation #TypeApplicationStatusSubmittedApproved