Keytruda - Europa

Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 Keytruda Procedural steps taken and scientific information after the authorisation Application number Scope Opinion/ Notification1 issued on Commission Decision Issued2 / amended on Product Information affected3 Summary IB/0119 - Deletion of - a pharmaceutical form 04/01/2022 SmPC, Labelling and PL II/0105 Extension of indication to include pembrolizumab in combination with lenvatinib for the treatment of 14/10/2021 15/11/2021 SmPC and PL Please refer to Scientific Discussion Keytruda -H -C -003820-II-0105 1 Notifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a type II variation or extension application or a worksharing application)

mismatch repair deficient (dMMR) colorectal cancer in adults for Keytruda based on the results from KEYNOTE-177 (an international, randomised, open-label Phase 3 trial of pembrolizumab versus chemotherapy in MSI-H or dMMR Stage IV Colorectal Carcinoma). As a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated. The Package

Loading..

Tags:

  Cancer, Chemotherapy, Colorectal cancer, Colorectal

Information

Related search queries