Ratioepo: Withdrawal of the marketing authorisation application

epoetin theta

Overview

On 25 February 2010, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ratioepo, for the treatment of symptomatic anaemia in adults with chronic renal failure or non-myeloid cancer.

Key facts

Name
Ratioepo
Product number
EMEA/H/C/001035
International non-proprietary name (INN) or common name
  • epoetin theta
Active substance
  • epoetin theta
Date of withdrawal
25/02/2010
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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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