The marketing authorisation for Rienso has been withdrawn at the request of the marketing authorisation holder.
Rienso : EPAR - Summary for the public (PDF/542.02 KB)
First published: 06/07/2012
Last updated: 13/07/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Takeda Pharma A/S
|Date of issue of marketing authorisation valid throughout the European Union||
13/04/2015 Rienso - EMEA/H/C/002215 - PSUV/0015
- 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.
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).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 201527/02/2015