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 01/06/2023

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
Therapeutic area (MeSH)
Essential Hypertension
Anatomical therapeutic chemical (ATC) code
C09DA07
GenericGeneric

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 and hybrid medicines.

Publication details
Marketing-authorisation holder
Actavis Group hf
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
13/03/2013
Contact address

Dalshraun 1
220 Hafnarfjörður
Iceland

Product information

31/05/2023 Actelsar HCT - EMEA/H/C/002676 - IG1612

Other EU languages available icon 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:

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

  • Angiotensin II 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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