Kyomarc: Withdrawal of the marketing authorisation application



On 17 October 2017, Amgen Europe BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kyomarc, for the treatment of cancer of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), kidney cancer, cervical cancer, and cancer of the ovary, the fallopian tube, or the peritoneum.

Key facts

Product number
International non-proprietary name (INN) or common name
  • bevacizumab
Active substance
  • bevacizumab
Date of withdrawal
Company making the application
Amgen Europe B.V.
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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