RegulatoryOfficial

Spain's AEMPS expects Lenzetto supply to resume mid-November as estradiol patch shortages persist

🇪🇸 AEMPS · Fri 30 Oct 2026

The medicines agency says Lenzetto spray should return progressively from mid-November, while some transdermal patches stay hard to obtain because of demand pushed up by the shortage.

Spain's medicines agency AEMPS has updated its guidance on transdermal estradiol hormone replacement therapy, expecting supply of Lenzetto (1.52 mg/dose transdermal spray) to be restored progressively from mid-November. Some estradiol patches will keep facing availability problems until then, it says. The update supplements an information note issued on 2 October.

Gedeon Richter, which markets Lenzetto, has kept its recovery forecast unchanged. The supply problem began in March 2026, and the company expects supply to normalise over the course of 2027. AEMPS says the loss of the spray has increased demand for the various patches, which in turn has affected their availability.

Currently available patch strengths are Estraderm matrix 25 mcg/24h, Estradot 37.5 and 75 mcg/24h, and Evopad and Estraderm matrix 100 mcg/24h. Supply of Evopad 25 and 50 mcg/24h is expected to resume on 5 November. The Estradot holder has said it will stop marketing the product once stock runs out, although AEMPS notes the brand has a very small share of the Spanish market and has little effect on the current situation. Laboratorios SEID reports low stock of Oestraclin 0.6 mg/g gel despite higher production, with the next delivery expected in the first week of November.

To limit the impact on patients, AEMPS has opened access to a limited number of Lenzetto units as a foreign medicine. The pharmacist at the designated foreign-medicine contact point in each autonomous community must apply through the agency's Medicines in Special Situations (MSE) application. AEMPS then assesses the request within 48 hours and, if authorised, the marketing authorisation holder delivers the product to the relevant point.

The agency says it is in continuous contact with estradiol companies to increase output and bring forward deliveries. It is also working with the Directorate-General for the Common Portfolio of Services of the National Health System and Pharmacy to improve availability of alternatives that are not reimbursed or have little presence in Spain. It is also approaching other authorities and companies about authorising presentations sold in other EU member states. At AEMPS's request, the EU has classed the issue as a critical supply problem requiring coordination among member states.

AEMPS and scientific societies have also drawn up a consensus document on clinical uses of oestrogen medicines and on using available formulations when supply is limited. It is meant to support clinical decisions, not replace usual practice or set general preferences between routes of administration, and individual patient assessment must continue. Noting that the transdermal route avoids first-pass liver metabolism and may offer safety advantages in some patients, particularly regarding thromboembolic risk, it recommends preferential transdermal use in women for whom oral therapy is clinically less suitable. As a temporary measure, it advises prioritising patches when starting treatment in patients who cannot take oral formulations because of relevant risk factors or other conditions. The source text is cut off before the remaining recommendations, including those on continuing existing treatment.

What it means for your team

  • Supply and QA teams in Spain should plan for continued patch constraints until at least mid-November, with the Evopad 25 and 50 mcg/24h restock expected on 5 November.
  • Hospital and community pharmacists can request Lenzetto as a foreign medicine through the MSE application; AEMPS aims to assess requests within 48 hours.
  • Estradot will be withdrawn once existing stock is exhausted, so market-access and supply planners should factor in the loss of that brand.
  • The EU's classification of the shortage as critical points to continued coordination among member states, and further authorisations of presentations from other EU countries may follow.

Official source: AEMPS ↗

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

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