Telmisartan Actavis

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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) for Telmisartan Actavis. 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 Telmisartan Actavis.

This EPAR was last updated on 31/08/2018

Authorisation details

Product details
Name
Telmisartan Actavis
Agency product number
EMEA/H/C/001168
Active substance
telmisartan
International non-proprietary name (INN) or common name
telmisartan
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09CA07
Generic

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 medicines.

Publication details
Marketing-authorisation holder
Actavis Group PTC ehf
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
30/09/2010
Contact address
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

21/08/2018 Telmisartan Actavis - EMEA/H/C/001168 - N/0018

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

  • List item

    Telmisartan Actavis-H-C-1168-A31-0007 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PR... (PDF/48.81 KB)


    First published: 29/09/2014
    Last updated: 29/09/2014

  • List item

    Telmisartan Actavis-H-C-1168-A31-0007 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

    Adopted

    First published: 29/09/2014
    Last updated: 29/09/2014
    EMA/PRAC/294920/2014

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