GovWire

MDR number

MDR 135-12/22

Company name

Albireo AB

Product name

Bylvay 1200 micrograms Hard Capsules, PLGB 36216/0004

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.

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.

Further Information

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

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

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