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BRIVIACT Film-coated tablets (2020)

Active ingredients: Brivaracetam

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.

Chemical substance
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 in multipacks containing 168 (3 packs of 56) filmcoated tablets in PVC/PCTFE – Aluminium blisters

Packs of 14 × 1 and 100 × 1 film-coated tablet in PVC/PCTFE – Aluminium blisters

Briviact 25 mg film-coated tablets:

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

Packs of 14 × 1 and 100 × 1 film-coated tablet in PVC/PCTFE – Aluminium blisters

Briviact 50 mg film-coated tablets:

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

Packs of 14 × 1 and 100 × 1 film-coated tablet in PVC/PCTFE – Aluminium blisters

Briviact 75 mg film-coated tablets:

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

Packs of 14 × 1 and 100 × 1 film-coated tablet in PVC/PCTFE – Aluminium blisters

Briviact 100 mg film-coated tablets:

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

Packs of 14 × 1 and 100 × 1 film-coated tablet in PVC/PCTFE – Aluminium blisters

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 14 January 2016

Marketing authorization number:

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