JusticeItaly Official institution

Italy cancels approval of Mylan's amlodipine/valsartan/hydrochlorothiazide tablets

Italy's medicines agency AIFA has cancelled the marketing permission for the blood pressure medicine Amlodipina/Valsartan/Idroclorotiazide Mylan Pharma after the license holder, Mylan S.p.a., asked to give it up. The cancellation was decided on 26 October 2026 and announced on 3 November 2026, covering several strengths and pack sizes of the tablets.

This summary was generated by AI; the official source prevails.

What does it mean?

Italy's medicines agency has removed the official permission to sell this combination blood pressure tablet, so these packs should no longer be sold under this approval. The change came because the company holding the permission asked to drop it, not because of a safety ruling stated in this notice.

Who is affected?

Patients who take this blood pressure tablet and pharmacies that stock it.