Availability of Elenium
Warsaw, October 7, 2025
Dear Sir or Madam,
In connection with the administrative decision of the Main Pharmaceutical Inspectorate concerning the withdrawal from the market of specific 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:
- The decision is preventive in nature and was made in order to maintain the highest standards of patient safety and compliance with applicable laws.
- The reservations do not concern the clinical efficacy of the product, but are of a qualitative nature and relate to the compliance of specific batches with the approved quality specification for the medicinal product.
- We are currently working closely with the regulatory authorities to clarify all aspects of the matter and to restore the product to distribution as soon as possible.
- We plan to resume manufacturing Elenium 10 mg in the fourth quarter of 2025 and Elenium 5 mg in March 2026.
- We do not plan to resume manufacturing Elenium 25 mg.
Some batches of Elenium may remain on the market and not be covered by the administrative decision, but they are in limited availability for patients, so we recommend contacting your doctor immediately.
⚠️ IMPORTANT WARNING
Elenium may be habit-forming and is not recommended for long-term use without close medical supervision.
Bearing in mind the continuity of therapy and pharmacological safety, we recommend that patients contact their attending physician immediately for an individual assessment of their clinical situation and the possible implementation of alternative therapy.
We assure you that patient safety is our highest priority. We make every effort to act with full transparency and responsibility in every situation.
Thank you for your trust and understanding.