MHRA Class 4 Medicines Defect Information: Briviact 75mg & 100mg film-coated tablets (Ethigen Limited)

Class 4 Medicines Defect Information:

Briviact 75mg & 100mg film-coated tablets (Ethigen Limited)

Drug alert number: EL (23)A/13

Date issued: 30 March 2023

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Briviact 75 mg film-coated tablets,  PLPI 18716/0146 

SNOMED Code: 37622711000001100

Batch number Expiry date Pack size First distributed
340132 30/09/2024 56 15-Nov-22
332075 28/02/2025 56 06-Dec-22

Active Pharmaceutical Ingredient: brivaracetam

Briviact 100 mg film-coated tablets,  PLPI 18716/0147 

SNOMED Code: 37622711000001101

Batch number Expiry date Pack size First distributed
332076 28/02/2025 56 09-Mar-22
329941 31/12/2024 56 09-May-22
337225 30/04/2025 56 30-May-22
332072 31/03/2025 56 01-Jun-22
329491 31/12/2024 56 08-Jun-22
337216 31/05/2025 56 09-Jun-22
339975 30/06/2025 56 27-Jun-22
337216 31/05/2025 56 29-Jul-22
343194 30/09/2025 56 14-Nov-22
349497 31/10/2025 56 16-Nov-22
343190 30/09/2025 56 12-Dec-22
349527 30/11/2025 56 14-Feb-23

Active Pharmaceutical Ingredient: brivaracetam

Brief description of the problem

Ethigen Limited have informed MHRA that due to a formatting error of the Patient Information Leaflet (PIL), incorrect and missing information about the colorant ingredients of the tablet coating was listed in Section 6 of the PIL:

Advice for healthcare professionals

There is no risk to product quality as a result of this issue. Healthcare professionals are advised to exercise caution when dispensing the above batches of the product. Where possible, please provide an updated copy of the PIL to the patient and remind the patient to read the leaflet in its entirety before using the medicine. These are available on the MHRA website by entering the product licence (PLPI) numbers. Alternatively, these may also be accessed via the links below:

Briviact 75mg film-coated tablets
Briviact 100mg film-coated tablets

Upon request, Ethigen Limited will post hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information.

View full alert here.

Advice for patients

This notification relates to a typographical error in the Patient Information Leaflet (PIL) relating to the ingredients of the tablet coating of the medicine. Patients do not need to take any action as the medicine itself is not affected. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.

Further Information

For medical information and stock control queries please contact the Regulatory Affairs Department at