RENVELA

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, South Africa, Spain, UK.

Active ingredients

The drug RENVELA contains one active pharmaceutical ingredient (API):

1
UNII 9YCX42I8IU - SEVELAMER CARBONATE
 

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.

 
Read more about Sevelamer

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 RENVELA Film-coated tablet MPI, EU: SmPC European Medicines Agency (EU)
 RENVELA Powder for oral suspension MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
V03AE02 Sevelamer V Various → V03 All other therapeutic products → V03A All other therapeutic products → V03AE Drugs for treatment of hyperkalemia and hyperphosphatemia
Discover more medicines within V03AE02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
CA Health Products and Food Branch 02354586, 02485559, 02485567
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 1405-MEE-0915
EE Ravimiamet 1422414, 1422425, 1422436, 1422447, 1422458, 1422469, 1780578
ES Centro de información online de medicamentos de la AEMPS 09521003, 09521007, 109521008
FI Lääkealan turvallisuus- ja kehittämiskeskus 036062, 036073, 478135
FR Base de données publique des médicaments 61136926, 63716917, 67392245
GB Medicines & Healthcare Products Regulatory Agency 181374, 182911, 368724, 375943, 381660, 393546
HK Department of Health Drug Office 60178
IL מִשְׂרַד הַבְּרִיאוּת 6690, 6691
IT Agenzia del Farmaco 039480037, 039480064
LT Valstybinė vaistų kontrolės tarnyba 1050558, 1050559, 1050560, 1050561, 1050562, 1050563, 1050564, 1086339, 1088300
NL Z-Index G-Standaard, PRK 207020, 90131, 90158
PL Rejestru Produktów Leczniczych 100054613, 100075650, 100087854, 100412917
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W54577001, W54577002, W54577003, W54578001, W54578002, W54579001, W54579002
SG Health Sciences Authority 13725P
US FDA, National Drug Code 58468-0130, 58468-0131, 58468-0132
ZA Health Products Regulatory Authority 45/32.16/0305

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