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Irish Medicines Database · HPRA register

BUCCOLAM 2.5 mg oromucosal solution

Authorisation EU/1/11/709/001 · Laboratorios Lesvi, S.L.

← All medicines
BUCCOLAM 2.5 mg oromucosal solution
Licence EU/1/11/709/001 · Unknown
Licence holder
Laboratorios Lesvi, S.L. (all products →)
Active substance
Midazolam
Dosage form
Oromucosal solution
Route of administration
Oromucosal use
ATC codes
N05CD, N05CD08
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.