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 regulatory@ethigen.co.uk

The post MHRA Class 4 Medicines Defect Information: Briviact 75mg & 100mg film-coated tablets (Ethigen Limited) appeared first on PSNC Website.