Rienso

ferumoxytol

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The marketing authorisation for Rienso has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Rienso : EPAR - Summary for the public BG = bălgarski 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public ES = español 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public CS = čeština 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public DA = dansk 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public DE = Deutsch 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public ET = eesti keel 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public EL = elliniká 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public EN = English 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public FR = français 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public IT = italiano 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public LV = latviešu valoda 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public LT = lietuvių kalba 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public HU = magyar 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public MT = Malti 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public NL = Nederlands 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public PL = polski 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public PT = português 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public RO = română 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public SK = slovenčina 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public SL = slovenščina 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public FI = suomi 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public SV = svenska 2012-07-06 2015-07-13
Rienso : EPAR - Summary for the public HR = Hrvatski 2012-07-06 2015-07-13

This EPAR was last updated on 13/07/2015 .

Authorisation details

Product details

Product details for Rienso
NameRienso
Agency product numberEMEA/H/C/002215
Active substance

ferumoxytol

International non-proprietary name (INN) or common name

ferumoxytol

Therapeutic area AnemiaKidney Failure, Chronic
Anatomical therapeutic chemical (ATC) code B03
Additional monitoring

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

Publication details

Publication details for Rienso
Marketing-authorisation holder

Takeda Pharma A/S

Revision7
Date of issue of marketing authorisation valid throughout the European Union15/06/2012

Contact address:

Takeda Pharma A/S
P.O. Box 260
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

Product information

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

Name Language First published Last updated
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - Product Information HR = Hrvatski 2012-07-06 2015-07-13

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.


Name Language First published Last updated
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13
Rienso : EPAR - All Authorised presentations HR = Hrvatski 2012-07-06 2015-07-13

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Rienso : EPAR - Public assessment report HR = Hrvatski 2012-07-06 2015-07-13
CHMP summary of positive opinion for Rienso HR = Hrvatski 2012-04-20 2015-07-13

Withdrawn

This medicine is now withdrawn from use in the European Union

More information about Rienso