PRAC starts review of Deanxit and human normal immunoglobulin safety signal
PRAC has begun a review of Deanxit, a fixed-dose combination for depression and anxiety, after reports of serious neurological and psychiatric side effects. PRAC also started a review of a safety signal concerning increased reporting of hypersensitivity reactions associated with specific batches of human normal immunoglobulin medicines, including Flebogamma DIF, Yimmugo and Gamunex that have been withdrawn.
Primary source
EMA news release, October 30, 2026
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26 - 29 October 2026
Read the source: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26 - 29 October 2026 ema.europa.eu
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