Regulatory PathRegulatory requirements compared

Active substances

Aliskiren + Hydrochlorothiazide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RASILEZ HCT 150/25MG FILM COATED TABLET150, 25 mgFilm-coated tablet · Oral use28 BlisterSAR 101.30NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
RASILEZ HCT 300/12.5MG FILM COATED TABLET300, 12.5 mgFilm-coated tablet · Oral use28 BlisterSAR 124.40NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
RASILEZ HCT 300/25MG FILM COATED TABLET300, 25 mgFilm-coated tablet · Oral use28 BlisterSAR 124.40NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
TEKTURNA HCTEQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralNODEN PHARMADiscontinued18 Jan 2008

EMA European Union — centrally authorised medicines

Rasilez HCT Noden Pharma DAC · Withdrawn · authorised 16 Jan 2009 · ATC C09XA52

Therapeutic indication (EMA)

Treatment of essential hypertension in adults. Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Rasilez 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.

Riprazo HCT Novartis Europharm Ltd. · Withdrawn · authorised 13 Apr 2011 · ATC C09XA52

Therapeutic indication (EMA)

Treatment of essential hypertension in adults. Riprazo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Rirpozo 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.

Sprimeo HCT Novartis Europharm Ltd. · Withdrawn · authorised 23 Jun 2011 · ATC C09XA52

Therapeutic indication (EMA)

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.

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.