Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Renvela 800 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). The white to off-white tablets are imprinted with “RENVELA 800” on one side. |
Each tablet contains 800 mg sevelamer carbonate.
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 |
|---|
|
Tablet core: Microcrystalline cellulose Film-coating: Hypromellose (E464) |
HDPE bottles with a polypropylene cap and a foil induction seal. Each bottle contains 30 tablets or 180 tablets.
Packs of 1 bottle of 30 or 180 tablets (without outer carton) and a multipack containing 180 (6 bottles of 30) tablets.
Not all pack sizes may be marketed.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
EU/1/09/521/001
EU/1/09/521/002
EU/1/09/521/003
Date of first authorisation: 10 June 2009
Date of latest renewal: 20 February 2019
| 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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