Rienso

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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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Rienso has been withdrawn at the request of the marketing authorisation holder.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 monitoringAdditional 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

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Select ‘available languages’ to access the language you need.

 

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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).

Assessment history

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