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Irish Medicines Database · HPRA register

EMSELEX

Authorisation EU/1/04/294/1-12 · pharmaand GmbH

← All medicines
EMSELEX
Licence EU/1/04/294/1-12 · Unknown
Licence holder
pharmaand GmbH (all products →)
Active substance
Darifenacin hydrobromide
Dosage form
Prolonged-release tablet
Route of administration
Oral use
ATC codes
G04BD, G04BD10
First authorised
22/10/2004
Prescription status
Product subject to prescription which may be renewed (B)
Supply
Supply through pharmacies only
Legal basis
Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.