Regulatory Decision Summary for Xeomin (IncobotulinumtoxinA)

The purpose of this submission is to seek marketing authorization for a third Xeomin vial strength of 200 units per vial in addition to the previously authorized strengths of 50 and 100 units per vial respectively. Introduction of the 200 units vial strength will reduce or remove the need to reconstitute multiple vials for therapeutic indications that require higher doses.

This authorization only applies to Xeomin indicated for therapeutic use and does not apply to Xeomin Cosmetic. There are no changes to the clinical indications or recommended dose for Xeomin.

The chemistry and manufacturing information submitted for Xeomin (200 units per vial) has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review, the final labelling and Product Monograph were considered to be acceptable.

Overall, the benefit-harm-uncertainty profile was favourable for Xeomin (200 units per vial) for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Xeomin, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.