Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042, Paris la Défense Cedex, France
Velphoro 500 mg chewable tablets.
| Pharmaceutical Form |
|---|
|
Chewable tablet. Brown, circular tablets embossed with PA500 on one side. Tablets have a 20 mm diameter and a thickness of 6.5 mm. |
Each chewable tablet contains sucroferric oxyhydroxide corresponding to 500 mg iron.
The sucroferric oxyhydroxide contained in one tablet is comprised of polynuclear iron (III)-oxyhydroxide (containing 500 mg iron), 750 mg sucrose and 700 mg starches (potato starch and pregelatinised maize starch).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sucroferric oxyhydroxide |
Sucroferric oxyhydroxide is also known as a mixture of polynuclear iron(III)-oxyhydroxide (pn-FeOOH), sucrose and starches. Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water and the phosphate ions throughout the physiological pH range of the gastrointestinal tract. Serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption. |
| List of Excipients |
|---|
|
Woodberry flavour |
High density polyethylene (HDPE) bottle with child-resistant polypropylene closure and foil induction seal, containing a molecular sieve desiccant and cotton. Pack sizes of 30 or 90 chewable tablets.
Child-resistant aluminium/aluminium perforated unit-dose blister, each blister containing 6 chewable tablets. Pack sizes of 30 × 1 or multipack of 90 (3 packs of 30 × 1) chewable tablets.
Not all pack sizes may be marketed.
Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042, Paris la Défense Cedex, France
EU/1/14/943/001
EU/1/14/943/002
EU/1/14/943/003
EU/1/14/943/004
Date of first authorisation: 26 August 2014
Date of latest renewal: 25 March 2019
| Drug | Countries | |
|---|---|---|
| VELPHORO | Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States |
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