Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Ethigen Limited, Briviact 75mg and 100mg film-coated tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Ethigen Limited has informed MHRA that the Patient Information Leaflet (PIL) in Briviact (brivaracetam) 75mg and 100mg film-coated tablets contains incorrect or missing information about the colorant ingredients of the tablet coating listed in Section 6 of the PIL. The affected products are:
- Briviact 75mg film-coated tablets (batch number: 340132, 332075)
- Briviact 100mg film-coated tablets (batch number: 332076, 329941, 337225, 332072, 329491, 337216, 339975, 337216, 343194, 349497, 343190, 349527)
For details of the incorrect and missing information, please refer to the website in MHRA.
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 products. 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-ethigen-limited-briviact-75mg-and-100mg-film-coated-tablets-el-23-a-slash-13
In Hong Kong, Briviact Tablets 100mg (HK-65939) is a pharmaceutical product registered by UCB Pharma (Hong Kong) Limited (UCB Pharma). The product is a prescription-only medicine. As confirmed with UCB Pharma, the affected batches have not been imported into Hong Kong.
Briviact 75mg film-coated tablets is not a registered pharmaceutical product in Hong Kong.
Ends/Friday, Mar 31, 2023
Issued at HKT 15:00
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