This brand name is authorized in 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
The drug RENVELA contains one active pharmaceutical ingredient (API):
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1
Sevelamer
UNII 9YCX42I8IU - SEVELAMER CARBONATE
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| RENVELA Powder for oral suspension | European Medicines Agency (EU) | MPI, EU: SmPC | |
| RENVELA Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| V03AE02 | Sevelamer | V Various → V03 All other therapeutic products → V03A All other therapeutic products → V03AE Drugs for treatment of hyperkalemia and hyperphosphatemia |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: CA | Health Products and Food Branch | Identifier(s): 02354586, 02485559, 02485567 |
| Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 1405-MEE-0915 |
| Country: EE | Ravimiamet | Identifier(s): 1422414, 1422425, 1422436, 1422447, 1422458, 1422469, 1780578 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 09521003, 09521007, 109521008 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 036062, 036073, 478135 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 61136926, 63716917, 67392245 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 181374, 182911, 368724, 375943, 381660, 393546 |
| Country: HK | Department of Health Drug Office | Identifier(s): 60178 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 6690, 6691 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 039480037, 039480064 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1050558, 1050559, 1050560, 1050561, 1050562, 1050563, 1050564, 1086339, 1088300 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 207020, 90131, 90158 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100054613, 100075650, 100087854, 100412917 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W54577001, W54577002, W54577003, W54578001, W54578002, W54579001, W54579002 |
| Country: SG | Health Sciences Authority | Identifier(s): 13725P |
| Country: US | FDA, National Drug Code | Identifier(s): 58468-0130, 58468-0131, 58468-0132 |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): 45/32.16/0305 |
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