Alofisel is indicated for the treatment of complex perinal fistulae in adult patients with nonactive/mildly active luminal Crohn's disease, when fistulae have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula. The below video details the Alofisel administration method and is provided as part of the product's risk management plan.
View the Alofisel 5 million cells/mL suspension for injection SmPC & PIL
IRE/WBC/18/0012a
Date of Preparation: August 2019