| EMA number | EMEA/H/C/002421 |
| ATC code | C09XA52 |
| Authorisation | 23 June 2011 |
| Withdrawn | 6 July 2012 |
| Revision | - |
Treatment of essential hypertension in adults. Sprimeo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Sprimeo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE — PH HEALTH, approved 2023-06-02 (ANDA206137).
147,296 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.