Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Velphoro   
Auth. number : EU/1/14/943
Active substance : mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V03 - All other therapeutic products
Pharmacological subgroup: V03A - All other therapeutic products
Chemical subgroup: V03AE - Drugs for treatment of hyperkalemia and hyperphosphatemia
Chemical substance: V03AE05 - Sucroferric oxyhydroxide
(See WHO ATC Index)
Indication: Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).
Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.
Marketing Authorisation Holder: Vifor Fresenius Medical Care Renal Pharma France
100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France
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
28/08/2014 Centralised - Authorisation EMEA/H/C/2705 (2014)6181 of 26/08/2014
21/11/2014 Centralised - Notification EMEA/H/C/2705/N/1
Updated with Decision(2016)5842 of 09/09/2016
17/09/2015 Centralised - Variation EMEA/H/C/2705/II/4/G
Updated with Decision(2016)5842 of 09/09/2016
01/09/2016 Centralised - Variation EMEA/H/C/2705/IB/07/G
Updated with Decision(2017)5433 of 26/07/2017
15/09/2016 Centralised - Yearly update (2016)5842 of 09/09/2016
28/07/2017 Centralised - Yearly update (2017)5433 of 26/07/2017