relevant for prescription [effects for which there is a demonstration or at least some evidence of a relationship with the therapeutic effect or which may induce A.D.R.]: they should be concisely described

In general no information is expected. In some cases e.g. in a new therapeutic area, main results (statistically compelling) regarding pre-specified clinically relevant endpoints from major trials, giving the main characteristics of the patient population could be mentioned here in condensed form. This is compulsory for drugs approved under exceptional circumstances. (Dir. 75/318/4G)