RegulatoryOfficial

Slovenian regulator publishes guidance on switching from Lenzetto spray to Estradiol Besins gel

🇸🇮 JAZMP · Thu 05 Nov 2026

JAZMP has issued a professional recommendation for moving patients from Lenzetto transdermal spray to Estradiol Besins transdermal gel, prepared by clinicians at University Medical Centre Ljubljana.

The Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) has published a professional recommendation on switching patients from Lenzetto transdermal spray to Estradiol Besins transdermal gel. The agency released it under the first indent of the sixteenth paragraph of Article 24 of the Medicinal Products Act.

The document was prepared at JAZMP's request by the Clinical Department of Reproduction at the Gynaecology Clinic of University Medical Centre Ljubljana. It was drawn up as part of discussions held by the Extended Professional Collegium for Gynaecology and Obstetrics.

The notice does not set out why the recommendation was needed, and it does not summarise the switching guidance. Any rationale and clinical detail are in the attached document, which was not part of the text reviewed here. The notice also does not mention a specific shortage.

JAZMP does advise following the availability and shortage status of both Estradiol Besins and Lenzetto in the Central Medicines Database and on the "Medicines on the market" page of its website. It says it publishes information on market launches, supply disruptions, and temporary or permanent cessations of marketing in those places.

What it means for your team

  • Teams with Lenzetto or Estradiol Besins in Slovenia should read the attached recommendation for the rationale and switching guidance, since the notice gives neither.
  • Market-access and supply teams should monitor the Central Medicines Database and JAZMP's market-availability page, which the agency names as its channels for supply disruption data.
  • Regulatory affairs staff may want to note that the recommendation came from a hospital clinical department and a professional collegium rather than from the agency itself.

Official source: JAZMP ↗

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

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