Actelsar HCT

RSS

telmisartan / hydrochlorothiazide

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Actelsar HCT. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Actelsar HCT.

For practical information about using Actelsar HCT, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 30/07/2018

Authorisation details

Product details
Name
Actelsar HCT
Agency product number
EMEA/H/C/002676
Active substance
  • telmisartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
telmisartan / hydrochlorothiazide
Anatomical therapeutic chemical (ATC) code
C09DA07
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic medicines.

Publication details
Marketing-authorisation holder
Actavis Group hf
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
13/03/2013
Contact address
Reykjavikurvegur 76-78
220 Hafnarfjörður
Iceland

Product information

19/06/2018 Actelsar HCT - EMEA/H/C/002676 - N/0017

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Angiotensin II receptor antagonists and diuretics

Therapeutic indication

Treatment of essential hypertension.

Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.

Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.

Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

Assessment history

Changes since initial authorisation of medicine

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