Availability of Elenium

Warsaw, January 20, 2026

Elenium Availability

Dear Sir or Madam,

Following the administrative decision of the Chief Pharmaceutical Inspectorate to withdraw from the market certain batches of the medicinal product:

• Elenium 5 mg, coated tablets
• Elenium 10 mg, coated tablets
• Elenium 25 mg, coated tablets

we would like to provide you with the following information:

• This decision is preventive in nature and was taken to maintain the highest standards of patient safety and compliance with applicable regulations.
• The concerns do not relate to the clinical efficacy of the product; they are qualitative in nature and concern the compliance of specific batches with the approved quality specifications of the medicinal product.
• We are currently working closely with the regulatory authorities to clarify all aspects of the matter and to restore product availability as soon as possible.
• We plan to resume production of Elenium 5 mg and 10 mg in the third quarter of 2026.
• We do not plan to resume production of Elenium 25 mg.

Some batches of the Elenium medicinal product not covered by the administrative decision may remain available on the market; however, their availability to patients may be limited. Therefore, we recommend that patients contact their doctor as soon as possible.

⚠️ IMPORTANT WARNING

The medicinal product Elenium may cause dependence and is not recommended for long-term use without close medical supervision.

In order to ensure continuity of therapy and pharmacological safety, we recommend that patients immediately consult their doctor to assess their individual clinical situation and, if necessary, initiate alternative treatment.

We assure you that patient safety is our highest priority, and we are committed to acting with full transparency and responsibility at all times.

Thank you for your trust and understanding.