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


Laboratorios Lesvi, S.L.EU/1/11/709/004

Main Information

Trade NameBuccolam
Active SubstancesMidazolam
Dosage FormOromucosal solution
Licence HolderLaboratorios Lesvi, S.L.
Licence NumberEU/1/11/709/004

Group Information

ATC CodeN05CD Benzodiazepine derivatives
N05CD08 midazolam


License statusAuthorised
Licence Issued05/09/2011
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017.
Marketing StatusUnknown


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