Quality & complianceOfficial

ŠÚKL publishes DHPC on Caelyx sterility and occupational exposure risk at cover removal

🇸🇰 ŠÚKL · Fri 30 Oct 2026

Slovakia's medicines agency has released a direct healthcare professional communication on Caelyx pegylated liposomal, citing possible loss of sterility and unintended exposure when the protective cover is removed.

The State Institute for Drug Control (ŠÚKL) in Slovakia published a Direct Healthcare Professional Communication (DHPC) on 30 October 2026 concerning Caelyx pegylated liposomal, the doxorubicin product.

The communication is titled as a warning of a risk of compromised product sterility and of unintended occupational exposure when the protective cover is removed. The notice sits in the agency's medicine safety section and links to a PDF of the full letter.

The text available to VigiEye consists of the page header, the publication date and the document title. It does not include the DHPC itself, so the handling instructions, the cause of the problem, affected batches and any recommended actions cannot be reported here.

As general context, a DHPC is a direct communication to healthcare professionals that conveys new important information on the safety, efficacy or correct use of a medicine.

What it means for your team

  • Hospital pharmacy and oncology teams in Slovakia should obtain and read the full DHPC PDF from ŠÚKL for the handling instructions.
  • Quality and pharmacy staff may wish to check how Caelyx is handled and prepared locally, in light of both the sterility and the staff exposure concerns.
  • Pharmacovigilance and regulatory teams should check whether equivalent communications are being issued in other markets; this cannot be confirmed from the source.

Official source: ŠÚKL ↗

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

More Quality & compliance All →