Sanofi-Aventis Announces Approval of Labelling Update of Acomplia® in Europe
Acomplia® labelling has been updated based on data reflecting one year of post-marketing experience mainly from Germany, France and the UK, as well as results of five additional clinical trials completed since the original dossier was approved.
With this updated labelling, Acomplia® is now contraindicated in patients with ongoing major depressive illness and/or ongoing anti-depressive treatment. “Special Warnings and Precautions” of the Summary of Product Characteristics (SmPC) have been updated as well to include information on depressive disorders.
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