Class 4 Medicines Defect Information:
Bylvay 1200 micrograms Hard Capsules (Albireo AB)
Drug alert number: EL (23)A/01
Date issued: 3 January 2023
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
Bylvay 1200 micrograms Hard Capsules, PLGB 36216/0004
17 October 2022
Active Pharmaceutical Ingredient: Odevixibat
Brief description of the problem
Albireo AB has informed the MHRA that the side panel of the bottle label of the above batch of Bylvay 1200 micrograms Hard Capsules erroneously reflected the content of the active ingredient as 400 micrograms odevixibat (as sesquihydrate).
This should state: “Each capsule contains 1200 micrograms odevixibat (as sesquihydrate)”.
The labelling on the main panel of the bottle label and the outer carton are printed correctly to reflect the capsule content as 1200 micrograms odevixibat. The patient information leaflet (PIL) also states that each Bylvay 1200 micrograms Hard Capsule contains 1200 micrograms odevixibat.
Advice for healthcare professionals
Healthcare professionals should note that there is no risk to product quality and efficacy, therefore the affected batch is not being recalled.
Healthcare professionals should exercise caution when dispensing or supplying this product. Please refer to the correct information on the content of the active ingredient as stated on the main panel of the bottle label and the outer carton of the pack.
View full alert here
Advice for patients
This notification relates to a typographical error on the label of the bottle for one affected batch of product. The medicine itself is not affected and patients do not need to take any action.
For medical information and stock control queries please contact: medinfo@Albireopharma.com
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