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International Work-sharing Initiative - Abemaciclib (Verzenio)

9 April 2019

Abemaciclib (Verzenio®) is the second medicine to be registered on the Australian Register of Therapeutic Goods (ARTG) that has been evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium's New Chemical Entities Work Sharing Initiative.

Efficiencies were achieved through the work-sharing of the evaluation between Health Canada and the Therapeutic Goods Administration, with each regulator taking a lead in the evaluation of different parts of the regulatory submission dossier. However, each regulator made independent decisions regarding approval (market authorisation) of the new medicine.

Abemaciclib will be sold under the name Verzenio® in both Australia and Canada, and is indicated for the treatment of breast cancer, expanding treatment options for patients in both countries.

For more information on this Work Sharing Initiative please see ACSS - NCE work-sharing pilot.