Posted by Michael Wonder on 05 Oct 2021
The Product Monograph for Protopic has been updated
4 October 2021 - LEO Pharma Inc. today announced that Health Canada has approved an update to the Product Monograph of Protopic (tacrolimus ointment 0.03% and 0.1%), removing the Serious Warnings and Precautions box, also referred to as a boxed warning, regarding a potential association with the use of topical calcineurin inhibitors and malignancy.
The removal of the Serious Warnings and Precautions box was based on Health Canada's review of two large, long-term, non-interventional, post-authorization safety studies focussing on the risk of cancer: APPLES (A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis) and JOELLE (JOint European Longitudinal Lymphoma and skin cancer Evaluation).
