Rasilez HCT
aliskiren / hydrochlorothiazide
Table of contents
Overview
The marketing authorisation for Rasilez HCT has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Rasilez HCT
|
| Agency product number |
EMEA/H/C/000964
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Hypertension
|
| Anatomical therapeutic chemical (ATC) code |
C09XA52
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Noden Pharma DAC
|
| Revision |
17
|
| Date of issue of marketing authorisation valid throughout the European Union |
16/01/2009
|
| Contact address |
D'Olier Chambers
16A D'Olier Street Dublin 2 Ireland |
Product information
20/12/2021 Rasilez HCT - EMEA/H/C/000964 -
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.