Unexpected adverse reaction

An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics [DIR 2001/83/EC Art 1(13)] 18 .

This includes class-related reactions which are mentioned in the summary of product characteristics (SmPC) but which are not specifically described as occurring with this product. For products authorised nationally, the relevant SmPC is that authorised by the competent authority in the Member State to whom the reaction is being reported. For centrally authorised products, the relevant SmPC is the SmPC authorised by the European Commission. During the time period between a CHMP opinion in favour of granting a marketing authorisation and the Commission decision granting the marketing authorisation, the relevant SmPC is the SmPC annexed to the CHMP opinion.

See also Summary of product characteristics