Notice type: Advisory
Bravecto Tablets were authorised by the European Commission on 11 February 2014, following the opinion of the Committee for Medical Products for Veterinary Use (CVMP) at the European Medicines Agency (EMA). Following a routine review of the worldwide adverse event experience with Bravecto tablets, the CVMP confirmed that the product continues to have a favourable benefit/risk profile but decided at their July 2017 meeting to request the marketing authorisation holder to update the product literature as follows:
The term ‘very rare’ is defined as reported in less than 1 animal in 10,000 animals. The product package leaflet is being updated accordingly but it is expected that it will take a number of months to be implemented.
The EMA has recently published a ’news item’ in relation to this matter.
Note that the new warnings apply only to the tablet formulation of Bravecto.