Pfizer’s Champix label updated to including new safety and efficacy data

Pfizer has updated the label of its smoking cessation aid Champix to include new safety and efficacy data.

The product's European Summary of Product Characteristics and package leaflet have been amended to reflect the findings of the EAGLES post-authorisation safety study, which was conducted in 16 countries to evaluate the neuropsychiatric safety of Champix.

As part of the update, the black triangle symbol – which indicated that additional safety monitoring for Champix in the EU was required – has been removed. This follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

Since its introduction in the EU nearly a decade ago, Champix has been prescribed to millions of patients and has been shown to be effective in helping people to stop smoking.

Dr Rory O'Connor, chief medical officer for internal medicine at Pfizer, said: "The new safety and efficacy information in the European label further supports the importance of Champix as a treatment option for healthcare providers and for those who are trying to quit smoking."

The company's meningococcal group B vaccine Trumenba was accepted for review by the European Medicines Agency earlier this month.