The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Sevelamer carbonate Zentiva



Genzyme Europe B.V.EU/1/14/952/005

Main Information

Trade NameSevelamer carbonate Zentiva
Active SubstancesSevelamer carbonate
Dosage FormPowder for oral suspension
Licence HolderGenzyme Europe B.V.
Licence NumberEU/1/14/952/005

Group Information

ATC CodeV03AE02 sevelamer

Status

License statusAuthorised
Licence Issued20/09/2018
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back