Is Aliskiren + Amlodipine approved by the US FDA?

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

Is Aliskiren + Amlodipine authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Aliskiren + Amlodipine.

Active substances

Aliskiren + Amlodipine

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
TEKAMLO	EQ 150MG BASE;EQ 5MG BASE; EQ 150MG BASE;EQ 10MG BASE; EQ 300MG BASE;EQ 5MG BASE; EQ 300MG BASE;EQ 10MG BASE	tablet · oral	NOVARTIS	Discontinued	26 Aug 2010

EMA European Union — centrally authorised medicines

Rasilamlo Novartis Europharm Ltd · Withdrawn · authorised 14 Apr 2011 · ATC C09XA53

Therapeutic indication (EMA)

Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.

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.