Rienso
Withdrawn
This medicine's authorisation has been withdrawn
ferumoxytol
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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The marketing authorisation for Rienso has been withdrawn at the request of the marketing authorisation holder.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
English (EN) (542.02 KB - PDF)
First published: Last updated:
български (BG) (626.83 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
español (ES) (541.35 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
čeština (CS) (606.5 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
dansk (DA) (540.89 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Deutsch (DE) (564.41 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
eesti keel (ET) (544.54 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
ελληνικά (EL) (629.77 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
français (FR) (564.64 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
hrvatski (HR) (563.78 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
italiano (IT) (545.59 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
latviešu valoda (LV) (606.35 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
lietuvių kalba (LT) (565.85 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
magyar (HU) (600.58 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Malti (MT) (609.06 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Nederlands (NL) (542.02 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
polski (PL) (603.97 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
português (PT) (547.26 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
română (RO) (565.46 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
slovenčina (SK) (606.88 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
slovenščina (SL) (598.33 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Suomi (FI) (561.26 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
svenska (SV) (563.36 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Product information
Rienso : EPAR - Product Information
English (EN) (963.78 KB - PDF)
First published: Last updated:
български (BG) (1.69 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
español (ES) (965.83 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
čeština (CS) (1.42 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
dansk (DA) (1.04 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Deutsch (DE) (1013.47 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
eesti keel (ET) (990.64 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
ελληνικά (EL) (1.74 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
français (FR) (1022.83 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
hrvatski (HR) (1007.46 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
íslenska (IS) (1004.63 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
italiano (IT) (1013.36 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
latviešu valoda (LV) (1.47 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
lietuvių kalba (LT) (1.02 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
magyar (HU) (1.49 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Malti (MT) (1.47 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Nederlands (NL) (974.35 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
norsk (NO) (989.08 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
polski (PL) (1.45 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
português (PT) (988.58 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
română (RO) (1.02 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
slovenčina (SK) (1.48 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
slovenščina (SL) (1.44 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Suomi (FI) (1.01 MB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
svenska (SV) (976.7 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Latest procedure affecting product information:
PSUV/0015
13/04/2015
This medicine’s product information is available in all official EU languages.
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).
Rienso : EPAR - All Authorised presentations
English (EN) (473.09 KB - PDF)
First published: Last updated:
български (BG) (507.08 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
español (ES) (472.73 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
čeština (CS) (499.29 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
dansk (DA) (472.04 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Deutsch (DE) (469.24 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
eesti keel (ET) (474.46 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
ελληνικά (EL) (506.91 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
français (FR) (472.9 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
hrvatski (HR) (487.11 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
íslenska (IS) (475.22 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
italiano (IT) (471.48 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
latviešu valoda (LV) (506.28 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
lietuvių kalba (LT) (485.47 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
magyar (HU) (488.44 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Malti (MT) (497.29 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Nederlands (NL) (469.38 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
norsk (NO) (470.92 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
polski (PL) (497.46 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
português (PT) (472.94 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
română (RO) (492.54 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
slovenčina (SK) (503.83 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
slovenščina (SL) (487.68 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
Suomi (FI) (470.68 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
svenska (SV) (471.89 KB - PDF)
First published: 06/07/2012Last updated: 13/07/2015
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 preparationsTherapeutic 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
Rienso : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (552.03 KB - PDF)
First published: Last updated:
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
English (EN) (612.97 KB - PDF)
First published: Last updated:
Rienso-H-C-2215-PSUV-0015 : EPAR - Assessment Report – Periodic safety update report
AdoptedReference Number: EMA/116238/2015
English (EN) (717.56 KB - PDF)
First published: Last updated:
Rienso-H-C-2215-PSUV-0014 : EPAR - Assessment Report
AdoptedReference Number: EMA/PRAC/404148/2014
English (EN) (758.76 KB - PDF)
First published: Last updated:
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
English (EN) (613.96 KB - PDF)
First published: Last updated:
Rienso : EPAR - Public assessment report
AdoptedReference Number: EMA/CHMP/221776/2012
English (EN) (1.43 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Rienso
AdoptedReference Number: EMA/CHMP/262205/2012
English (EN) (501.37 KB - PDF)
First published: Last updated:
News on Rienso
More information about Rienso
Public statement on Rienso (ferumoxytol): Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/437901/2015
English (EN) (106.28 KB - PDF)
First published: Last updated:
More information on Rienso
This page was last updated on