BRIVIACT Film-coated tablet Ref.[6625] Active ingredients: Brivaracetam

Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium

Product name and form

Briviact 10 mg film-coated tablets.
Briviact 25 mg film-coated tablets.
Briviact 50 mg film-coated tablets.
Briviact 75 mg film-coated tablets.
Briviact 100 mg film-coated tablets.

Pharmaceutical Form
Film-coated tablet (tablet). Briviact 10 mg film-coated tablets: White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with ‘u10’ on one side. Briviact 25 mg film-coated tablets: Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and debossed with ‘u25’ on one side. Briviact 50 mg film-coated tablets: Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm and debossed with ‘u50’ on one side. Briviact 75 mg film-coated tablets: Purple, oval film-coated tablets with dimensions of 13.0 mm x 7.3 mm debossed with ‘u75’ on one side. Briviact 100 mg film-coated tablets: Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1 mm and debossed with ‘u100’ on one side.

Qualitative and quantitative composition

Briviact 10 mg film-coated tablets: Each film-coated tablet contains 10 mg brivaracetam.

Briviact 25 mg film-coated tablets: Each film-coated tablet contains 25 mg brivaracetam.

Briviact 50 mg film-coated tablets: Each film-coated tablet contains 50 mg brivaracetam.

Briviact 75 mg film-coated tablets: Each film-coated tablet contains 75 mg brivaracetam.

Briviact 100 mg film-coated tablets: Each film-coated tablet contains 100 mg brivaracetam.

Excipient(s) with known effect:

Briviact 10 mg film-coated tablets: Each 10 mg film-coated tablet contains 88 mg lactose.

Briviact 25 mg film-coated tablets: Each 25 mg film-coated tablet contains 94 mg lactose.

Briviact 50 mg film-coated tablets: Each 50 mg film-coated tablet contains 189 mg lactose.

Briviact 75 mg film-coated tablets: Each 75 mg film-coated tablet contains 283 mg lactose.

Briviact 100 mg film-coated tablets: Each 100 mg film-coated tablet contains 377 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Brivaracetam	Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells. Although the exact role of this protein remains to be elucidated it has been shown to modulate exocytosis of neurotransmitters.

List of Excipients
Core Croscarmellose Sodium Lactose monohydrate Betadex Lactose anhydrous Magnesium stearate Coating Briviact 10 mg film-coated tablets: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350 Talc Briviact 25 mg film-coated tablets: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350 Talc Iron oxide yellow (E172) Iron oxide black (E172) Briviact 50 mg film-coated tablets: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350 Talc Iron oxide yellow (E172) Iron oxide red (E172) Briviact 75 mg film-coated tablets: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350 Talc Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Briviact 100 mg film-coated tablets: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350 Talc Iron oxide yellow (E172) Iron oxide black (E172)

Pack sizes and marketing

Briviact 10 mg film-coated tablets:

Packs of 14, 56 film-coated tablets and multipacks containing 168 (3 packs of 56) film-coated tablets in PVC/PCTFE – Aluminium blisters
Packs of 14 × 1 and 100 × 1 film-coated tablets in PVC/PCTFE – Aluminium blisters

Briviact 25 mg film-coated tablets:

Packs of 14, 56 film-coated tablets and multipacks containing 168 (3 packs of 56) film-coated tablets in PVC/PCTFE – Aluminium blisters
Packs of 14 × 1 and 100 × 1 film-coated tablets in PVC/PCTFE – Aluminium blisters

Briviact 50 mg film-coated tablets:

Packs of 14, 56 film-coated tablets and multipacks containing 168 (3 packs of 56) film-coated tablets in PVC/PCTFE – Aluminium blisters
Packs of 14 × 1 and 100 × 1 film-coated tablets in PVC/PCTFE – Aluminium blisters

Briviact 75 mg film-coated tablets:

Packs of 14, 56 film-coated tablets and multipacks containing 168 (3 packs of 56) film-coated tablets in PVC/PCTFE – Aluminium blisters
Packs of 14 × 1 and 100 × 1 film-coated tablets in PVC/PCTFE – Aluminium blisters

Briviact 100 mg film-coated tablets:

Packs of 14, 56 film-coated tablets and multipacks containing 168 (3 packs of 56) film-coated tablets in PVC/PCTFE – Aluminium blisters
Packs of 14 × 1 and 100 × 1 film-coated tablets in PVC/PCTFE – Aluminium blisters

Not all pack sizes may be marketed.

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/15/1073/001
EU/1/15/1073/002
EU/1/15/1073/003
EU/1/15/1073/004
EU/1/15/1073/005
EU/1/15/1073/006
EU/1/15/1073/007
EU/1/15/1073/008
EU/1/15/1073/009
EU/1/15/1073/010
EU/1/15/1073/011
EU/1/15/1073/012
EU/1/15/1073/013
EU/1/15/1073/014
EU/1/15/1073/015
EU/1/15/1073/016
EU/1/15/1073/017
EU/1/15/1073/018
EU/1/15/1073/019
EU/1/15/1073/020
EU/1/15/1073/023
EU/1/15/1073/024
EU/1/15/1073/025
EU/1/15/1073/026
EU/1/15/1073/027

Date of first authorisation: 14 January 2016
Date of latest renewal: 9 October 2020

Drugs

Drug	Countries
BRIVIACT	Austria, Australia, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Mexico, Netherlands, Poland, Romania, Turkey, United Kingdom, United States

Next: Usage >

© 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.