Velphoro
sucroferric oxyhydroxide
Table of contents
Overview
Velphoro is a medicine used to control blood-phosphate levels in patients with long-term kidney disease:
- in adults who are on haemodialysis or peritoneal dialysis to remove waste products from the blood;
- in children aged from 2 years with severe kidney disease, including those on dialysis.
Velphoro should be used with a low-phosphate diet and other treatments such as calcium and vitamin D supplements which help to control bone disease linked to kidney failure and high phosphate levels.
The active substance in this medicine is sucroferric oxyhydroxide (also known as mixture of polynuclear iron(III)-oxyhydroxide, sucrose (sugar) and starches).
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List item
Velphoro : EPAR - Medicine overview (PDF/150.99 KB)
First published: 13/10/2014
Last updated: 26/11/2020
EMA/580042/2020 -
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List item
Velphoro : EPAR - Risk-management-plan summary (PDF/427.78 KB)
First published: 13/10/2014
Last updated: 26/11/2020
Authorisation details
Product details | |
---|---|
Name |
Velphoro
|
Agency product number |
EMEA/H/C/002705
|
Active substance |
Sucroferric oxyhydroxide
|
International non-proprietary name (INN) or common name |
sucroferric oxyhydroxide
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
V03AE05
|
Publication details | |
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Marketing-authorisation holder |
Vifor Fresenius Medical Care Renal Pharma France
|
Revision |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
26/08/2014
|
Contact address |
100-101 Terrasse Boieldieu
Tour Franklin- La Défense 8 92042 Paris la Défense Cedex France |
Product information
16/11/2020 Velphoro - EMEA/H/C/002705 - X/0020/G
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
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 is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate <30 mL/min/1.73 m²) or with CKD on dialysis.
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.