RegulatoryOfficial

Infarmed allows English-labelled Fixapost to cover Monoprost Duo stock-out in Portugal

🇵🇹 INFARMED · Mon 26 Oct 2026

Portugal's regulator has exceptionally authorised an Irish-sourced, English-labelled latanoprost/timolol single-dose eye drop to limit the impact of the Monoprost Duo shortage.

Infarmed, the Portuguese medicines authority, has authorised on an exceptional basis the use of an English-labelled latanoprost/timolol eye drop to reduce the impact of a stock shortage of Monoprost Duo. The decision was set out in Circular Informativa n.º 098/CD/100.20.200, dated 26 October 2026.

The product is Fixapost 50 micrograms/ml + 5 mg/ml eye drops, a solution in single-dose containers. Its strength is given as 0.01 mg/0.2 ml + 1 mg/0.2 ml, matching the Monoprost Duo presentation affected by the shortage. The pack contains 30 units of 0.2 ml. The marketing authorisation holder is Laboratoires Théa, and the stock originates in Ireland.

Packs will carry a Portuguese-language patient leaflet, although the outer labelling remains in English. The circular lists a retail price (PVP) of €18.84 and reimbursement of 90%.

To ease access, Infarmed has assigned this presentation the same registration number as the authorised product on the Portuguese market, 5749577. As a result, prescribing and dispensing can proceed as usual. The circular does not state how long the measure will last, nor does it give batch details or the expected duration of the shortage.

What it means for your team

  • Supply and market-access teams should note that the foreign-labelled pack shares the national registration number, so existing prescribing and reimbursement routes apply.
  • Quality and labelling teams should check that handling procedures cover English-labelled outer packs supplied with a Portuguese leaflet.
  • Pharmacovigilance teams may want to ensure product identification, such as the Fixapost name and origin, is captured accurately in adverse-event reports, since the shared registration number could obscure which product was used.
  • The circular gives no end date or batch information, so companies should watch for further Infarmed updates.

Official source: INFARMED ↗

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

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