EMA · Safety reviews ongoing
EMA PRAC opens reviews of Deanxit and immunoglobulin safety reports
Official source date: · Source checked
October PRAC highlights describe a review of Deanxit following neurological and psychiatric adverse-event reports, and an investigation into increased allergic reactions associated with specific immunoglobulin batches.
Who should review this?
Pharmacovigilance, product-quality and regulatory teams responsible for the affected products.
What it means for pharmaceutical teams
The two investigations address different safety questions. Product and batch information should be evaluated against the relevant official communication; an open signal review is not a final conclusion on causality.
Practical review checklist
PharmaEdges reading prompts for your own applicability review:
- Check whether your product portfolio or batch records are relevant.
- Review the official communications with pharmacovigilance and quality colleagues.
- Monitor EMA for conclusions and any product-specific measures.
Official source and verification
Read the EMA source (opens in a new tab)
This article summarises the linked official material. The context and checklist are PharmaEdges explanatory commentary, not additional regulatory requirements. The source publication date is separate from this article’s publication date.
For a correction, contact PharmaEdges with the article URL and supporting source. Read our news publishing policy.
Related regulatory news
- EDQM highlights international API inspection cooperation report
- CDSCO issues notice on raw-material and finished-formulation testing
- CDSCO lists ONDLS monitoring notice for high-risk solvent supply chains
- EMA announces permanent clinical-trial application advice from January 2027
- EMA publishes year-end 2026 advice for type I variation submissions