Tolucombi

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 Tolucombi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tolucombi.

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

This EPAR was last updated on 26/03/2019

Authorisation details

Product details
Name
Tolucombi
Agency product number
EMEA/H/C/002549
Active substance
  • telmisartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
telmisartan / hydrochlorothiazide
Therapeutic area (MeSH)
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
Krka, d.d., Novo mesto
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
13/03/2013
Contact address
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

08/01/2018 Tolucombi - EMEA/H/C/002549 - R/0020

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

telmisartan and diuretics

Therapeutic indication

Tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 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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