Rienso

RSS

ferumoxytol

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Rienso has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 13/07/2015

Authorisation details

Product details
Name
Rienso
Agency product number
EMEA/H/C/002215
Active substance
Ferumoxytol
International non-proprietary name (INN) or common name
ferumoxytol
Therapeutic area (MeSH)
  • Anemia
  • Kidney Failure, Chronic
Anatomical therapeutic chemical (ATC) code
B03
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
15/06/2012
Contact address
P.O. Box 260
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

13/04/2015 Rienso - EMEA/H/C/002215 - PSUV/0015

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Anti anaemic preparations

Therapeutic indication

Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD).

The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).

Assessment history

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