VELTASSA Powder for oral suspension Ref.[8679] Active ingredients: Patiromer

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

Product name and form

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.

Qualitative and quantitative composition

Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium).

Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium).

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.

List of Excipients

Xanthan gum

Pack sizes and marketing

8.4 g, 16.8 g or 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.

Marketing authorization holder

Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

Marketing authorization dates and numbers

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

Date of first authorisation: 19 July 2017

Drugs

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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