Transcription of Keytruda - Europa
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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).
negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD L1 with a CPS ≥ 10, based on the results from the pivotal KEYNOTE-590 (KN590) trial. As a consequence, sections 4.1, 4.2, 4.8, 5.1, 5.2 and 5.3 of the SmPC are updated. The Package Leaflet is updated in accordance. Minor updates are also included in Annex
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