Micardis

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telmisartan

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

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 of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 06/09/2018

Authorisation details

Product details
Name
Micardis
Agency product number
EMEA/H/C/000209
Active substance
telmisartan
International non-proprietary name (INN) or common name
telmisartan
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09CA07
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
16/12/1998
Contact address
Bingerstr. 173
55216 Ingelheim am Rheim
Germany

Product information

22/05/2018 Micardis - EMEA/H/C/000209 - IB/0114/G

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 antagonists
  • plain

Therapeutic indication

Hypertension

Treatment of essential hypertension in adults.

Cardiovascular prevention

Reduction of cardiovascular morbidity in patients with:

  • manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;
  • type-2 diabetes mellitus with documented target-organ damage.

Assessment history

Changes since initial authorisation of medicine

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