During the PRAC meeting in November 2026, a safety review was initiated following an increase in reports of hypersensitivity reactions associated with specific batches of medicines containing normal human immunoglobulin. Reported reactions ranged in severity from skin manifestations to serious allergic reactions, including anaphylaxis and angioedema.

The PRAC will assess the available data to clarify the possible causes of this issue and determine whether additional risk minimisation measures are needed.

The PRAC also initiated a safety review of Deanxit (flupentixol/melitracen), a medicine indicated for the treatment of depression and anxiety, following reports of serious neurological and psychiatric adverse reactions.

Deanxit is currently not authorised in Italy.