Rasilez HCT
aliskiren / hydrochlorothiazide
Table of contents
Overview
Rasilez HCT is a medicine used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that no specific cause for the hypertension can be found.
Rasilez HCT is used in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide taken alone. It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active substances.
The medicine contains the active substances aliskiren and hydrochlorothiazide.
Authorisation details
| Product details | |
|---|---|
| Name |
Rasilez HCT
|
| Agency product number |
EMEA/H/C/000964
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
aliskiren / hydrochlorothiazide
|
| Therapeutic area (MeSH) |
Hypertension
|
| Anatomical therapeutic chemical (ATC) code |
C09XA52
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Noden Pharma DAC
|
| Revision |
16
|
| Date of issue of marketing authorisation valid throughout the European Union |
16/01/2009
|
| Contact address | |
Product information
11/12/2018 Rasilez HCT - EMEA/H/C/000964 - IAIN/0091
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Agents acting on the renin-angiotensin system
Therapeutic indication
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.