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PRODUCT DETAIL

BUCCOLAM 10 mg orálny roztok

Code 10917
MA number EU/1/11/709/004
Product Form: sol ora 4x2 ml/10 mg (striek.orálna napln.PP)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 57 - HYPNOTICA, SEDATIVA
ATC:
N NERVOUS SYSTEM
N05 PSYCHOLEPTICS
N05C HYPNOTICS AND SEDATIVES
N05CD Benzodiazepine derivatives
N05CD08 Midazolam
Shelf life: 24
Container: pre-filled oral syringe PP
Route of admin.: Oromucosal use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(3) hybrid application
MA issued: 05.09.2011
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 28.05.2022
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