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The marketing authorisation for Rienso has been withdrawn at the request of the marketing authorisation holder.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 | |
Product information
13/04/2015 Rienso - EMEA/H/C/002215 - PSUV/0015
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.
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).