Authorized Use: An advertisement is misleading if it suggests that a drug is useful in a broader range of conditions or patients than that which have been approved by Health Canada. The segment of patients for whom the product is authorized should set the context for the corresponding benefits. Also, the indication(s) should be stated in a manner that clearly reflects the Terms of Market Authorization.
Presentation of indication
Any content setting the boundaries for patient selection from the Indications and Clinical Use section of the Product Monograph (or equivalent section of other TMA types) must be presented prominently among, or prior to, the first set of marketing benefit claims in the APS. This is only required for the indication(s) promoted within the piece. The same applies to the recommended use for products with a product license.
The TMA content “Drug X is indicated for” (or equivalent) must be presented verbatim at least once within the advertising message of the APS.