Rienso: Withdrawal of the application to change the marketing authorisation
ferumoxytol
Table of contents
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 |
|
Active substance |
|
Date of withdrawal |
19/01/2015 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal letter Rienso (PDF/18.78 KB)
First published: 27/02/2015
Last updated: 27/02/2015 -
List item
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Rienso (ferumoxytol) (PDF/79.83 KB)
First published: 27/02/2015
Last updated: 27/02/2015
EMA/119454/2015
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').