For more information

Intended to introduce the link to the complete TMA and to direct the reader to it for more information about adverse events, drug interactions, and dosing (and dosing adjustments where applicable). The link must be presented in a manner which is consistent with section 7.3 of the PAAB code.
e.g. “Please consult the product monograph at www.product.ca/TMA22211 for important information relating to adverse reactions, drug interactions, and dosing information”.

Health Canada had also requested that a phone number be included in case the HCP has limited access to the internet.

Risks in the TMA Dosing/Administration or Interaction sections that are emphasized (e.g. bolded, boxed, all-caps, underlined, or framed as “serious” or equivalent), must be identified in the linkage statement. Specifically, the linkage statement should include copy directing the HCP to the TMA for information relating to the interaction type or the required type of dosing adjustments.

e.g. “Please consult the product monograph at www.product.ca/TMA25456 for important information relating to adverse reactions, drug interactions (particularly interactions with CYP3A4), and dosing information”.

e.g. “Please consult the product monograph at www.product.ca/TMA44332 for important information relating to adverse reactions, drug interactions, and for dosing information (particularly special dosing considerations in patients with severe renal disease).