PharmacovigilanceOfficial

PRAC reviews rising allergic reaction reports linked to batches of normal human immunoglobulin medicines

🇬🇷 EOF · Wed 04 Nov 2026

Greece's EOF reports that the EMA safety committee is examining batch-specific allergic reactions with immunoglobulin products and has opened a separate review of Deanxit.

The Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing a growing number of reports of allergic reactions associated with specific batches of normal human immunoglobulin medicines. The information comes from the Greek medicines agency EOF, which published a summary of the committee's 26–29 October 2026 meeting.

EOF's notice does not say which products or batches are involved, how many reports have been received, or what outcome the review could have. Those details are not given in the text available.

The committee is also starting a review of Deanxit, a medicine combining flupentixol and melitracen that is used as an antidepressant and anxiolytic. The EOF summary does not set out the scope of that review or the safety concern behind it.

EOF directs readers to its full announcement and to the European Medicines Agency (EMA) website, where the complete PRAC highlights are published. As general context, PRAC is the EMA committee responsible for assessing and monitoring the safety of medicines used in the EU.

What it means for your team

  • Marketing authorisation holders for normal human immunoglobulin products should check the full PRAC highlights on the EMA website for the products and batches concerned.
  • Pharmacovigilance teams may wish to review recent allergic reaction case reports for immunoglobulin products, including batch information, in line with their internal procedures.
  • Companies marketing Deanxit or other flupentixol/melitracen products should look for the scope of the new review in the EMA documentation, as EOF's summary does not state it.

Official source: EOF ↗

Article written by VigiEye from the official source (EOF). AI-assisted; check the source before acting.

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