RegulatoryOfficial

PEI issues Rote-Hand-Brief on Respreeza over possible compromised container integrity

🇩🇪 Paul-Ehrlich-Institut · Fri 30 Oct 2026

Germany's Paul-Ehrlich-Institut has published a Dear Healthcare Professional letter warning that Respreeza's primary container may be compromised, risking missed doses and infections.

The Paul-Ehrlich-Institut (PEI) published a Rote-Hand-Brief on 30 October 2026 for Respreeza, a human alpha-1 proteinase inhibitor. The letter concerns the risk of a missed dose and potential infections linked to compromised integrity of the product's primary container.

A Rote-Hand-Brief is the German format for a Dear Healthcare Professional letter. Marketing authorisation holders use it to pass on important new safety or quality information to prescribers and other professionals, usually in agreement with the competent authority.

The material available to VigiEye consists of the letter's title and the PEI's listing page. It does not set out the affected batches, the cause of the container problem or the specific actions requested. Readers should consult the full letter on the PEI website for those details.

The PEI lists the notice under its safety information for blood products.

What it means for your team

  • Pharmacovigilance and quality teams should retrieve the full Rote-Hand-Brief to confirm affected batches and the actions required.
  • Missed doses and potential infections are the two patient-safety risks named in the letter; these may be relevant to case assessment and to reports of lack of effect or infection.
  • Regulatory affairs teams handling Respreeza should check how the communication is being distributed to healthcare professionals and whether any further local follow-up is needed.

Official source: Paul-Ehrlich-Institut ↗

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

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