Rienso

Withdrawn

This medicine's authorisation has been withdrawn

ferumoxytol

Overview

On 13 April 2015, the European Commission withdrew the marketing authorisation for Rienso (ferumoxytol) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Takeda Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Rienso was granted marketing authorisation in the EU on 15 June 2012 for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease. The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Rienso is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Rienso : EPAR - Summary for the public

Reference Number: EMA/289652/2012

Product information

Rienso : EPAR - Product Information

Rienso : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Rienso
• 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

Pharmacotherapeutic group

Other antianemic 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).

Authorisation details

• EMA product number:
  EMEA/H/C/002215
• Marketing authorisation holder:
  Takeda Pharma A/S

  P.O. Box 260; Dybendal Alle 10; 2630 Taastrup; Denmark

• Marketing authorisation issued:
  15/06/2012
• Withdrawal of marketing authorisation:
  13/04/2015
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Rienso : EPAR - Procedural steps taken and scientific information after authorisation

Rienso-H-C-2215-PSUV-0015 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/116275/2015

Rienso-H-C-2215-PSUV-0015 : EPAR - Assessment Report – Periodic safety update report

Adopted Reference Number: EMA/116238/2015

Rienso-H-C-2215-PSUV-0014 : EPAR - Assessment Report

Adopted Reference Number: EMA/PRAC/404148/2014

Rienso-H-C-2215-PSUV-0014 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/722014/2014

Initial marketing authorisation documents

Rienso : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/221776/2012

CHMP summary of positive opinion for Rienso

Adopted Reference Number: EMA/CHMP/262205/2012