PharmacovigilanceOfficial

European Commission grants marketing authorisation for GSK's Lynavoy (linerixibat)

🇪🇺 European Commission (Union Register) · Thu 22 Oct 2026

Commission Decision (2026) 7688 of 22 October 2026 authorises Lynavoy, held by GlaxoSmithKline Trading Services Limited, for the EU market.

The European Commission has granted a new marketing authorisation for Lynavoy (linerixibat). The holder is GlaxoSmithKline Trading Services Limited, according to the Union Register entry dated 22 October 2026.

The authorisation was issued through Commission Decision (2026) 7688 of 22 October 2026. The related EMA procedure number is EMEA/H/C/006241/0000.

The decision marks the product's entry onto the EU market. The register entry itself does not set out the product information or the conditions of the authorisation, and the source text available for this report contained no further detail.

As context, a centrally authorised medicine normally comes with an agreed risk management plan and post-authorisation pharmacovigilance obligations. These apply from the point of authorisation.

What it means for your team

  • Pharmacovigilance teams should check the full product information and risk management plan once published, as the register entry gives no detail on them.
  • Regulatory affairs teams can log Commission Decision (2026) 7688 and procedure EMEA/H/C/006241/0000 as the reference identifiers for Lynavoy.
  • Market-access teams should note that the authorisation is the point of EU market entry, but pricing and reimbursement are not covered by this decision.

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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