Class 4

Class 4 Medicines Defect Information: Albireo AB, Bylvay 1200 micrograms Hard Capsules, EL (23)A/01

Albireo AB has informed the MHRA that there is a typographical error with the text on the side panel of the bottle label for a specific batch of Bylvay 1200 micrograms Hard Capsules.

MDR Number: MDR 135-12/22

Company name: Albireo AB

Product description: Bylvay 1200 micrograms Hard Capsules, PLGB 36216/0004

Details of the affected batch:

Batch number

Expiry date

Pack size

First distributed

W067208E

01-2024

30 capsules

17 October 2022

Brief description of 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 to 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.

Advice to 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.

Company contacts for further information:

For medical information and stock control queries please contact: medinfo@Albireopharma.com

To access the full recall: Class 4 Medicines Defect Information: Albireo AB, Bylvay 1200 micrograms Hard Capsules, EL (23)A/01