CHMP adopted a request for supplementary information with a specific timetable regarding the proposed update to sections 4.4 and 5.1 of the SmPC to incorporate efficacy and safety data from the final results of study CLEE011A3201C (RIGHT Choice). (European Medicines Agency) - Oct 12, 2026 - CHMP Final Minutes of the meeting on 20 - 23 Apr
2026 CHMP • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology
|