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Irish Medicines Database · HPRA register

Epistatus 10 mg oromucosal solution

Authorisation PA20595/002/001 · SERB S.A.

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Epistatus 10 mg oromucosal solution
Licence PA20595/002/001 · Not marketed
Licence holder
SERB S.A. (all products →)
Active substance
Midazolam
Dosage form
Oromucosal solution
Route of administration
Oromucosal use
ATC code
N05CD08
First authorised
07/08/2020
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Hybrid application (Article 10(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.