Pritor

RSS

telmisartan

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

Overview

This is a summary of the European public assessment report (EPAR) for Pritor. 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 Pritor.

This EPAR was last updated on 26/04/2018

Authorisation details

Product details
Name
Pritor
Agency product number
EMEA/H/C/000210
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
Bayer AG
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
11/12/1998
Contact address
51368 Leverkusen
Germany

Product information

13/04/2018 Pritor - EMEA/H/C/000210 - T/0124

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

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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