Rienso: Withdrawal of the application to change the marketing authorisation

ferumoxytol

Overview

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

Name
Rienso
Product number
EMEA/H/C/002215
Date of issue of market authorisation valid throughout the European Union (if applicable)
15/06/2012
International non-proprietary name (INN) or common name
  • ferumoxytol
Active substance
  • Ferumoxytol
Date of withdrawal
19/01/2015
Company making the application
Takeda Pharma A/S
Withdrawal type
Post-authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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