Following previous communications concerning the hospitalisation of female patients after the administration of a product containing botulinum toxin type A and the suspected use of falsified Dysport, the Institute for Medicines and Medical Devices of Montenegro (CInMED) informs the public that, acting at the request of the competent authorities, it has conducted an authenticity verification of a product labelled as Dysport 500, manufactured by Ipsen, bearing batch number S05061 and an expiry date of 02/2028.

CInMED has not issued an import authorisation for the batch in question. Further verification, carried out in cooperation with the manufacturer, Ipsen, confirmed that the batch of Dysport bearing these identification details is not genuine. Specifically, the product bearing these details was not manufactured for any market and is therefore considered a falsified medicinal product.

At the same time, CInMED, in cooperation with the manufacturer, conducted additional checks on batches of Dysport distributed through the legal supply chain in Montenegro. These checks confirmed that no quality defects have been reported for these batches, nor have any quality concerns been identified in other countries.

Accordingly, genuine Dysport that has been imported and distributed in compliance with the applicable regulatory requirements may continue to be used without restriction in authorised healthcare institutions.

CInMED will continue to take appropriate measures within its regulatory mandate and cooperate with the competent authorities to prevent the illegal distribution of falsified medicinal products and safeguard public health.