Safety Information
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- Safety Information should be fully visible and not require clicking to view the content.
- Code section 2.4: The advertising copy should provide sufficient information to permit assessment of risk/benefit in a prominent manner, whereby the prominence of risk information must be comparable to the prominence of benefit in the main body copy.
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Verbatim indication statement (from PM) needs to appear in the APS, and it does not.
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In relevant warnings and precautions, immune-mediated pneumonitis is missing and should be listed to show complete information.
- Code 2.4.2: Limitations cited in the TMA should be included in the body copy.
- The link to the PM is somewhat hidden at the very bottom of the piece. It should be featured prominently in the main body of the APS.
- Code Section 7.3:
Advertising with Product Claim Link to Terms of Market Authorization:
One of the following must appear prominently within the main advertising message of the APS:
Electronic link(s) to the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant)
URL(s) for a webpage containing the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) accompanied by a statement that these documents are also available upon request through a stated phone number.