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Infarmed clears Refixia for hospital use in children under 12 with haemophilia B

🇵🇹 INFARMED · Thu 05 Nov 2026

Portugal's medicines authority has published the public funding assessment report for nonacog beta pegol, which is now authorised for hospital use in young haemophilia B patients.

Infarmed, the Portuguese medicines authority, announced on 5 November 2026 that Refixia (nonacog beta pegol) has been authorised for use in the hospital setting in Portugal.

The authorisation covers the treatment and prophylaxis of bleeding in patients with haemophilia B, a congenital deficiency of factor IX, who are under 12 years of age. The notice names no other indications.

The public report on the assessment is now available on Infomed, Infarmed's medicines database, on the product's own page. It can also be found on the Infarmed page dedicated to funding decisions. The headline of the notice also says the request for prior evaluation was approved.

The notice contains no safety information and no details of pricing, contract terms or the date of availability in hospitals. Teams wanting the reasoning behind the decision will need to read the published report.

What it means for your team

  • Market-access teams can consult the public assessment report on Infomed and on Infarmed's funding decisions page to see the basis for the decision.
  • The authorisation is limited to hospital use in haemophilia B patients under 12; the notice mentions no wider population.
  • The notice raises no safety or pharmacovigilance issues, so it needs no PV action.
  • Commercial terms and the timing of hospital availability are not covered in the notice.

Official source: INFARMED ↗

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

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