Tolura

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 Tolura. 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 Tolura.

This EPAR was last updated on 12/10/2018

Authorisation details

Product details
Name
Tolura
Agency product number
EMEA/H/C/001196
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
Krka, d.d., Novo mesto 
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
04/06/2010
Contact address
Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

17/09/2018 Tolura - EMEA/H/C/001196 - IB/0029

Contents

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 or peripheral arterial disease) or;
  • type 2 diabetes mellitus with documented target organ damage.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating