Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France
Veltassa 1 g powder for oral suspension.
Veltassa 8.4 g powder for oral suspension.
Veltassa 16.8 g powder for oral suspension.
Veltassa 25.2 g powder for oral suspension.
| Pharmaceutical Form |
|---|
|
Powder for oral suspension. Off white to light brown powder, with occasional white particles. |
Veltassa 1 g powder for oral suspension: Each sachet contains 1 g patiromer (as patiromer sorbitex calcium)
Veltassa 8.4 g powder for oral suspension: Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium).
Veltassa 16.8 g powder for oral suspension: Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium).
Veltassa 25.2 g powder for oral suspension: Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Patiromer |
Patiromer is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol complex as a counterion. Patiromer increases faecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels. |
| List of Excipients |
|---|
|
Xanthan gum (for information about sorbitol see section 4.4) |
1 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
Pack sizes: box of 60 sachets.
8.4 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
Pack sizes: boxes of 30, 60 or 90 sachets and multipacks comprising 3 cartons, each containing 30 sachets.
16.8 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
Pack sizes: boxes of 30, 60 or 90 sachets.
25.2 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
Pack sizes: boxes of 30, 60 or 90 sachets.
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/1/17/1179/001
EU/1/17/1179/002
EU/1/17/1179/003
EU/1/17/1179/004
EU/1/17/1179/005
EU/1/17/1179/006
EU/1/17/1179/007
EU/1/17/1179/008
EU/1/17/1179/009
EU/1/17/1179/010
EU/1/17/1179/011
Date of first authorisation: 19 July 2017
Date of latest renewal: 24 March 2022
| Drug | Countries | |
|---|---|---|
| VELTASSA | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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