Page contentsKey factsDecisionRelated contentKey facts Invented name Lumykras Active Substance sotorasib Therapeutic area Oncology Decision number P/0089/2023 PIP number EMEA-002690-PIP02-22 Pharmaceutical form(s) All pharmaceutical forms Condition(s) / indication(s) Treatment of colorectal carcinoma Route(s) of administration All routes of administration Contact for public enquiries Amgen Europe B.V United Kingdom pipenquiry@amgen.com + 44 1223420305 + 44 1223426814 Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 10/03/2024DecisionP/0089/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for sotorasib (Lumykras), (EMEA-002690-PIP02-22)Reference Number: EMA/74651/2023 English (EN) (204.51 KB - PDF)First published: 05/04/2024ViewRelated contentLumykrasShare this page