Omontys: Withdrawal of the marketing authorisation application


On 28 June 2013, Takeda Global Research and Development Centre (Europe) officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Omontys, for the treatment of symptomatic anaemia associated with chronic kidney disease in adult patients undergoing dialysis.

Key facts

Product number
Active substance
  • peginesatide
Date of withdrawal
Company making the application
Takeda Global Research and Development Centre (Europe)
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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