Is Aliskiren + Amlodipine + Hydrochlorothiazide approved by the US FDA?

Drugs@FDA lists 1 application product line for Aliskiren + Amlodipine + Hydrochlorothiazide, including AMTURNIDE (Discontinued).

Is Aliskiren + Amlodipine + Hydrochlorothiazide authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Aliskiren + Amlodipine + Hydrochlorothiazide.

Active substances

Aliskiren + Amlodipine + Hydrochlorothiazide

US FDA 1
EMA 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
AMTURNIDE	EQ 150MG BASE;EQ 5MG BASE;12.5MG; EQ 300MG BASE;EQ 5MG BASE;12.5MG; EQ 300MG BASE;EQ 5MG BASE;25MG; EQ 300MG BASE;EQ 10MG BASE;12.5MG; EQ 300MG BASE;EQ 10MG BASE;25MG	tablet · oral	NOVARTIS	Discontinued	21 Dec 2010

EMA European Union — centrally authorised medicines

Rasitrio Novartis Europharm Ltd. · Withdrawn · authorised 22 Nov 2011 · ATC C09XA54

Therapeutic indication (EMA)

Rasitrio is indicated for the treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose level as in the combination.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.