When constructing Fair Balance, under "Other relevant warnings & precautions," are we required to include caution in use within certain patient populations where no/limited safety or efficacy data are available? In this situation, patients with certain medical conditions were excluded from the clinical trials, as is standard with other brands in the category.
When it comes to product specific questions, it is best to speak to the reviewer as they will be familiar with the brand and therapeutic area, and there may be other considerations within the TMA that determine if it is required. As a general rule of thumb, this type of statement from the warnings and precautions section would be required if implications/consequences are conveyed such as "not recommended" or "lower the dose".