MicardisPlus

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 MicardisPlus. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for MicardisPlus.

This EPAR was last updated on 31/05/2017

Authorisation details

Product details
Name
MicardisPlus
Agency product number
EMEA/H/C/000413
Active substance
  • telmisartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
telmisartan / hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DA07
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
19/04/2002
Contact address
Bingerstr. 173
55216 Ingelheim am Rheim
Germany

Product information

06/04/2017 MicardisPlus - EMEA/H/C/000413 - WS/1110

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

Agents acting on the renin angiotensin system

Therapeutic indication

Treatment of essential hypertension.

MicardisPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.

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

Assessment history

Changes since initial authorisation of medicine

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