Dafiro HCT
amlodipine besilate / valsartan / hydrochlorothiazide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Authorisation details
Product details | |
---|---|
Name |
Dafiro HCT
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Agency product number |
EMEA/H/C/001160
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Hypertension
|
Anatomical therapeutic chemical (ATC) code |
C09DX01
|
Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
25
|
Date of issue of marketing authorisation valid throughout the European Union |
03/11/2009
|
Contact address |
Vista Building |
Product information
15/12/2022 Dafiro HCT - EMEA/H/C/001160 - WS/2373
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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 as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Assessment history
News
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28/06/2013
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17/05/2013
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
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20/10/2011