PharmacovigilanceOfficial

European Commission withdraws marketing authorisation for HIV combination Trizivir from ViiV Healthcare

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

Commission Decision (2026) 7741 of 23 October 2026 withdraws the authorisation for Trizivir (abacavir/lamivudine/zidovudine); the reason is not stated in the available source.

The European Commission has withdrawn the marketing authorisation for Trizivir, the fixed-dose combination of abacavir, lamivudine and zidovudine held by ViiV Healthcare BV. The step is recorded in Commission Decision (2026) 7741, dated 23 October 2026, and listed in the Union Register.

The source material available to VigiEye does not give a reason for the withdrawal. It also does not say whether the decision followed a request from the marketing authorisation holder or arose from another procedure, and it gives no information on effective dates for supply or on any transition arrangements.

Because the rationale is unknown, no conclusions should be drawn about the product's safety, quality or efficacy from the decision alone. Companies and regulators will need to consult the full Union Register entry and the decision text for detail.

As general context, a withdrawn centralised authorisation means the product no longer has a valid EU-wide licence, which has knock-on effects for product databases, labelling and any continuing pharmacovigilance responsibilities.

What it means for your team

  • Update internal product and authorisation records to reflect Decision (2026) 7741 of 23 October 2026 for Trizivir.
  • Check the Union Register entry for the withdrawal details, as the reason is not stated in the source used here.
  • PV teams should review any continuing obligations tied to the product, including PSURs, the risk management plan and literature monitoring.
  • Quality and supply teams should confirm the status of any remaining stock, labelling and distribution activities against the 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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