Rienso
ferumoxytol
Table of contents
Overview
The marketing authorisation for Rienso has been withdrawn at the request of the marketing authorisation holder.
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) |
|
| Anatomical therapeutic chemical (ATC) code |
B03
|
Additional 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
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).
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
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).