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


EMSELEX



zr pharma& GmbHEU/1/04/294/1-12

Main Information

Trade NameEMSELEX
Active SubstancesDarifenacin hydrobromide
Dosage FormProlonged-release tablet
Licence Holderzr pharma& GmbH
Licence NumberEU/1/04/294/1-12

Group Information

ATC CodeG04BD Drugs for urinary frequency and incontinence
G04BD10 darifenacin

Status

License statusAuthorised
Licence Issued22/10/2004
Legal statusProduct subject to prescription which may be renewed (B)
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