Brancaster Pharma Limited have notified the Medicines and Healthcare products Regulatory Agency (MHRA) of an issue relating to the label affixed to the 5mL ampoule of Water for Injections (solvent) that is packaged in each finished product pack.
This label is not in accordance with the approved marketing authorisation: it is written in French language rather than English, and relates to the approved French benzathine benzylpenicillin combination product (“Extencilline”).
The Water for Injections for the French product is identical to the approved UK product, except for the labelling on the ampoule. The label affixed to the vials of benzylpenicillin benzathine powder, outer carton of the finished product packs and patient information leaflets for the above batches are in accordance with the marketing authorisations.
Further information and actions for healthcare professionals can be found on the MHRA website.