Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rienso   
Auth. number : EU/1/12/774
INN : Ferumoxytol
ATC: Pending
Indication: Rienso is indicated for the intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).The diagnostic of iron deficiency must be based on appropriate laboratory tests.
Marketing Authorisation Holder: Takeda Pharma A/S
PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/06/2012 Centralised - Authorisation EMEA/H/C/2215 (2012)4209 of 15/06/2012
01/08/2012 Centralised - Variation EMEA/H/C/2215/IA/1/G
Updated with Decision(2012)7885 of 29/10/2012
20/08/2012 Centralised - Variation EMEA/H/C/2215/N/2
Updated with Decision(2012)7885 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7885 of 29/10/2012
16/04/2013 Centralised - Variation EMEA/H/C/2215/IAin/5
Updated with Decision(2013)3774 of 11/06/2013
13/06/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2215/T/6 (2013)3774 of 11/06/2013
05/11/2013 Centralised - Variation EMEA/H/C/2215/IB/10
Updated with Decision(2014)561 of 29/01/2014
31/01/2014 Centralised - Variation EMEA/H/C/2215/IB/12 (2014)561 of 29/01/2014