Lutholaz: Withdrawal of the marketing authorisation application
YES Pharmaceutical Development Services GmbH withdrew its application for a marketing authorisation of Lutholaz for use in cancer patients to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and prevent febrile neutropenia (neutropenia accompanied by fever due to an infection). Neutropenia is a common side effect of cancer chemotherapy and can leave patients vulnerable to infections.
The company withdrew the application on 19 July 2023.
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Related information on withdrawals
A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').