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 05/01/2021

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
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
Actavis Group PTC ehf
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
29/09/2010
Contact address
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

08/12/2020 Telmisartan Actavis - EMEA/H/C/001168 - IA/0021

Contents

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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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