Rienso: Withdrawal of the application to change the marketing authorisation



On 19 January 2015, Takeda Pharma A/S officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Rienso, in the treatment of anaemia (low levels of red blood cells or of haemoglobin, the iron-containing pigment in the blood) due to iron deficiency in patients with any underlying condition.

Key facts

Product number
Date of issue of market authorisation valid throughout the European Union (if applicable)
International non-proprietary name (INN) or common name
  • ferumoxytol
Active substance
  • Ferumoxytol
Date of withdrawal
Company making the application
Takeda Pharma A/S
Withdrawal type

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

How useful was this page?

Add your rating