其 他 安 全 警 示
|
| |
| The United Kingdom: Class 4 Medicines Defect Information: Albireo AB, Bylvay 1200 micrograms Hard Capsules (English only) |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Albireo AB has informed the MHRA that the side panel of the bottle label of one batch of Bylvay 1200 micrograms Hard Capsules (batch number: W067208E) 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 also states that each Bylvay 1200 micrograms Hard Capsule contains 1200 micrograms odevixibat.
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-albireo-ab-bylvay-1200-micrograms-hard-capsules-el-23-a-slash-01
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Jan 4, 2023
Issued at HKT 14:00
|
| |
