Other relevant warnings and precautions

The rest of the warnings and precautions relating to promoted indications are identified (i.e. listed). In other words, each bullet simply identify the risk without the description provided in the TMA. However, the manufacturer may elect to include additional information (e.g. patient subsets to which the risks apply).

When multiple indications are promoted in the piece, it should be clear which indication each risk/burden pertains to.

Each distinct warning or precaution should appear in a separate bullet (unless grouped together in the TMA). However, items may be grouped into categories considered by the PAAB to be adequately descriptive.

e.g. separate warning regarding red blood cell reduction, white blood cell reduction, and platelet reductions could be identified as “reduction in blood cells”

e.g. separate warning about risks pertaining to lymphoma, skin cancer, and lung cancer could be identified as “risks of malignancies”.