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.

Key facts

Product number
Active substance
  • pegfilgrastim
Date of withdrawal
Company making the application
YES Pharmaceutical Development Services GmbH
Withdrawal type
Initial authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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