Velphoro

RSS

iron

Authorised
This medicine is authorised for use in the European Union.

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).

This EPAR was last updated on 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
iron
Therapeutic area (MeSH)
  • Hyperphosphatemia
  • Renal Dialysis
Anatomical therapeutic chemical (ATC) code
V03AE05
Publication details
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

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Pharmacotherapeutic group

Drugs for treatment of hyperkalemia and hyperphosphatemia

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.

Assessment history

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