FRISIUM Tablet Ref.[51042] Active ingredients: Clobazam

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Frisium 10mg Tablets.

Pharmaceutical Form

Tablet.

A white, circular, biconvex tablet having the monogram ‘Hoechst’ engraved on one face and the identifying codes ‘B’ and ‘GL’ and a single score-line on the other.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains 10 mg clobazam.

Excipients: each tablet contains 72.3mg lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Clobazam

Clobazam is a 1,5-benzodiazepine and the pharmacodynamic activity is qualitatively similar to that of other compounds of the class of Muscle relaxant, Anxiolytic, Sedative, Hypnotic, Anticonvulsant, Amnesic.

List of Excipients

Lactose monohydrate
Maize starch
Colloidal anhydrous silica
Talc
Magnesium stearate

Pack sizes and marketing

PVC/Aluminium foil blister packs of 100 tablets.

Marketing authorization holder

Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0540/043/001

Date of first authorisation: 25th August 1980
Date of last renewal: 25th August 2010

Drugs

Drug Countries
FRISIUM Austria, Brazil, Cyprus, Germany, Estonia, Finland, Hong Kong, Ireland, Israel, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.