PharmacovigilanceOfficial

EMA publishes list of centrally authorised products with safety-related product information changes

🇪🇺 EMA · Fri 30 Oct 2026

The European Medicines Agency has issued a list of centrally authorised medicines whose product information has been changed for safety reasons, dated 30 October 2026.

The European Medicines Agency (EMA) has published a document titled "List of centrally authorised products with safety-related changes to the product information", dated 30 October 2026.

The material available to VigiEye gave only the title and date. It did not include the list's contents, so the products, active substances and specific safety changes cannot be reported here.

As general context, the product information of a centrally authorised medicine comprises the summary of product characteristics for healthcare professionals and the package leaflet for patients. Safety-related updates to these texts usually reach the market through variations to the marketing authorisation.

Marketing authorisation holders and healthcare professionals should consult the full EMA document for the entries that apply to their products.

What it means for your team

  • Pharmacovigilance and regulatory affairs teams should check the full EMA list against their own centrally authorised portfolios.
  • Where a product is listed, confirm that the summary of product characteristics and package leaflet changes are reflected in internal documents and in national implementation.
  • Quality and labelling teams should verify that any listed update is carried through to artwork and packaging on the required timelines.

Official source: EMA ↗

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

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