Rasilez Lxo Ireland Designated Activity Company · Authorised · authorised 22 Aug 2007 · ATC C09XA02
Therapeutic indication (EMA)
Treatment of essential hypertension.
Active substance
Aliskiren
- SFDA 2
- US FDA 3
- EMA 5
- US price lines 3
- Safety 7
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| RASILEZ 150MG F.C. TABLETS | 150 mg | Film-coated tablet · Oral use | 28 Blister | SAR 98.10 | NCE · Prescription | NOVARTIS | Withdrawn by regulatory authority · Not Marketed |
| RASILEZ 300MG F.C. TABLETS | 300 mg | Film-coated tablet · Oral use | 28 Blister | SAR 120.50 | NCE · Prescription | NOVARTIS | Withdrawn by regulatory authority · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TEKTURNA | EQ 150MG BASE; EQ 300MG BASE | tablet · oral | LXO IRELAND | Prescription | 5 Mar 2007 |
| ALISKIREN HEMIFUMARATE | EQ 150MG BASE; EQ 300MG BASE | tablet · oral | PH HEALTH | Prescription | 22 Mar 2019 |
| TEKTURNA | EQ 37.5MG BASE | capsule, pellet · oral | NODEN PHARMA | Discontinued | 14 Nov 2017 |
EMA European Union — centrally authorised medicines
Enviage Novartis Europharm Ltd. · Withdrawn · authorised 22 Aug 2007 · ATC C09XA02
Therapeutic indication (EMA)
Treatment of essential hypertension
Sprimeo Novartis Europharm Ltd. · Withdrawn · authorised 22 Aug 2007 · ATC C09XA02
Therapeutic indication (EMA)
Treatment of essential hypertension.
Tekturna Novartis Europharm Ltd. · Withdrawn · authorised 22 Aug 2007 · ATC C09XA02
Therapeutic indication (EMA)
Treatment of essential hypertension
Riprazo Novartis Europharm Ltd. · Withdrawn · authorised 22 Aug 2007 · ATC C09XA02
Therapeutic indication (EMA)
Treatment of essential hypertension.
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ALISKIREN 150 MG TABLET | $3.93745 | per EA | 23 Sep 2026 |
| US NADAC | ALISKIREN 300 MG TABLET | $5.85836 | per EA | 23 Sep 2026 |
| US NADAC | TEKTURNA 300 MG TABLET | $15.09446 | per EA | 6 Jan 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 28 Sep 2020 TEKTURNA HCT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 17 Jun 2020 TEKTURNA — safety-related labeling change
Labeling sections changed: Contraindications; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 4 Nov 2016 AMTURNIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 4 Nov 2016 TEKAMLO — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 12 Feb 2015 PRAC signal: Severe hyponatraemia leading to neurological symptoms
Action for MAH: update of the product information: No - MHRA 11 Dec 2014 Aliskiren (Rasilez▼): risk of cardiovascular and renal adverse reactions
New contraindications and warnings for combination of aliskiren (Rasilez) with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). - MHRA 11 Dec 2014 Aliskiren (Rasilez▼): risk of angioedema and renal dysfunction
Use of aliskiren can cause angioedema, a rare and serious side effect, and or acute renal failure.
Combinations containing Aliskiren
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.