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). Opinions are issued for all other procedures.
Notifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a type II va riation or extension application or a worksharing application). Opinions are issued for all other procedures.
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