Non-UK marketing authorisation number on the label of the ampoules for batch 0112391R

For Healthcare Professionals

There is currently no UK-labelled Fentanyl 50 micrograms/ml Solution for Injection (10ml ampoules) manufactured by Martindale Pharma available for distribution in the UK. In order to prevent a disruption of supply, one batch of product that was labelled for distribution in Saudi Arabia (batch 0112391R) will be released in the UK. While the ampoules have been labelled with non-UK labelling, this batch of product was manufactured in the UK, and the manufacturing process is identical to the registered manufacturing process of the UK product. In agreement with the MHRA and the Department of Health and Social Care (DHSC), Martindale Pharma has repackaged the ampoules into cartons with UK-approved labelling and patient information leaflet (PIL).