Rienso

Withdrawn

This medicine's authorisation has been withdrawn

ferumoxytol

Overview

The marketing authorisation for Rienso has been withdrawn at the request of the marketing authorisation holder.

Rienso : EPAR - Summary for the public

Reference Number: EMA/289652/2012

Product information

Rienso : EPAR - Product Information

Latest procedure affecting product information: PSUV/0015

13/04/2015

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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
• 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

AdoptedReference Number: EMA/116238/2015

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

AdoptedReference 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

AdoptedReference Number: EMA/CHMP/221776/2012

CHMP summary of positive opinion for Rienso

AdoptedReference Number: EMA/CHMP/262205/2012