RENVELA Powder for oral suspension Ref.[8161] Active ingredients: Sevelamer

Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Product name and form

Renvela 2.4 g powder for oral suspension.

Pharmaceutical Form
Powder for oral suspension. Pale yellow powder.

Qualitative and quantitative composition

Each sachet contains 2.4 g sevelamer carbonate.

Excipient with known effect: This medicine contains 25.27 mg propylene glycol alginate (E405) in each 2.4 g sachet.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Sevelamer	Sevelamer is a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become protonated in the stomach. These protonated amines bind negatively charged ions such as dietary phosphate in the intestine.

List of Excipients
Propylene glycol alginate (E405) Citrus cream flavour Sodium chloride Sucralose Iron oxide yellow (E172)

Pack sizes and marketing

Sachet of ethylene methacrylic acid copolymer, polyester, LDPE and aluminium foil laminate, with a heat seal.

Each sachet contains 2.4 g of sevelamer carbonate. Each carton contains 60 or 90 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Marketing authorization dates and numbers

EU/1/09/521/006
EU/1/09/521/007

Date of first authorisation: 10 June 2009
Date of latest renewal: 20 February 2019

Drugs

Drug	Countries
RENVELA	Austria, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States, South Africa

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