PharmacovigilanceOfficial

Commission withdraws marketing authorisation for Orion's Entacapone Orion from Union Register

🇪🇺 European Commission (Union Register) · Fri 23 Oct 2026

Decision (2026) 7739 removes Entacapone Orion (entacapone), held by Orion Corporation, from the Union Register; no reason for the withdrawal has been given.

The European Commission has issued Decision (2026) 7739 withdrawing the marketing authorisation for Entacapone Orion from the Union Register of medicinal products. The entry was published on 23 October 2026.

The product contains the active substance entacapone, and the marketing authorisation holder is Orion Corporation.

The material available does not state why the authorisation was withdrawn. It is therefore unclear whether the step is a commercial decision or relates to another matter, and no assumption should be drawn either way.

As general context, a withdrawal from the Union Register means the centrally authorised product no longer holds a valid EU marketing authorisation. Companies and healthcare supply chains typically need to reflect that change in their records.

What it means for your team

  • Check the Union Register entry and the Commission decision text to establish the grounds for withdrawal, as none are given in the item.
  • Update internal product databases and regulatory information systems to reflect the withdrawn status of Entacapone Orion.
  • Review any PSUR, RMP and wider pharmacovigilance obligations linked to the product with your PV and QA colleagues.
  • Confirm supply-chain and market-access implications, including any remaining stock or pending commitments for the product.

Official source: European Commission (Union Register) ↗

Article written by VigiEye from the official source (European Commission (Union Register)). AI-assisted; check the source before acting.

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