Telmisartan Teva

telmisartan

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Telmisartan Teva has been withdrawn at the request of the marketing-authorisation holder.

List item

Telmisartan Teva : EPAR - Summary for the public (PDF/646.62 KB)

First published: 22/03/2010
Last updated: 26/06/2015
- Bulgarian
  (PDF/1.89 MB)
- Croatian
  (PDF/1.75 MB)
- Czech
  (PDF/1.27 MB)
- Danish
  (PDF/1.2 MB)
- Dutch
  (PDF/1.2 MB)
- Estonian
  (PDF/1.22 MB)
- Finnish
  (PDF/1.2 MB)
- French
  (PDF/1.2 MB)
- German
  (PDF/1.2 MB)
- Greek
  (PDF/1.3 MB)
- Hungarian
  (PDF/1.27 MB)
- Italian
  (PDF/1.2 MB)
- Latvian
  (PDF/1.25 MB)
- Lithuanian
  (PDF/1.22 MB)
- Maltese
  (PDF/1.26 MB)
- Polish
  (PDF/1.28 MB)
- Portuguese
  (PDF/1.2 MB)
- Romanian
  (PDF/1.25 MB)
- Slovak
  (PDF/1.26 MB)
- Slovenian
  (PDF/1.25 MB)
- Spanish
  (PDF/1.2 MB)
- Swedish
  (PDF/1.2 MB)

This EPAR was last updated on 17/09/2021

Authorisation details

Product details
Name	Telmisartan Teva
Agency product number	EMEA/H/C/001146
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 and hybrid medicines.

Publication details
Marketing-authorisation holder	Teva B.V.
Revision	11
Date of issue of marketing authorisation valid throughout the European Union	25/01/2010
Contact address	Swensweg 5 2031GA Haarlem The Netherlands

Product information

09/02/2021 Telmisartan Teva - EMEA/H/C/001146 - IA/0027

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Telmisartan Teva : EPAR - Product Information (PDF/1.14 MB)

First published: 22/03/2010
Last updated: 25/03/2021
- Bulgarian
  (PDF/3.71 MB)
- Croatian
  (PDF/2.27 MB)
- Czech
  (PDF/3.22 MB)
- Danish
  (PDF/2.02 MB)
- Dutch
  (PDF/2.07 MB)
- Estonian
  (PDF/2.1 MB)
- Finnish
  (PDF/2.02 MB)
- French
  (PDF/2.1 MB)
- German
  (PDF/2.08 MB)
- Greek
  (PDF/3.82 MB)
- Hungarian
  (PDF/3.2 MB)
- Icelandic
  (PDF/2.01 MB)
- Italian
  (PDF/2.04 MB)
- Latvian
  (PDF/3.48 MB)
- Lithuanian
  (PDF/2.17 MB)
- Maltese
  (PDF/3.36 MB)
- Norwegian
  (PDF/2.02 MB)
- Polish
  (PDF/3.27 MB)
- Portuguese
  (PDF/2.07 MB)
- Romanian
  (PDF/2.2 MB)
- Slovak
  (PDF/3.22 MB)
- Slovenian
  (PDF/3.09 MB)
- Spanish
  (PDF/2.07 MB)
- Swedish
  (PDF/2.02 MB)

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

List item

Telmisartan Teva : EPAR - All Authorised presentations (PDF/581.99 KB)

First published: 22/03/2010
Last updated: 09/08/2012
- Bulgarian
  (PDF/1.31 MB)
- Croatian
  (PDF/657.35 KB)
- Czech
  (PDF/1.21 MB)
- Danish
  (PDF/1.13 MB)
- Dutch
  (PDF/1.13 MB)
- Estonian
  (PDF/1.13 MB)
- Finnish
  (PDF/1.13 MB)
- French
  (PDF/1.13 MB)
- German
  (PDF/1.13 MB)
- Greek
  (PDF/1.25 MB)
- Hungarian
  (PDF/1.24 MB)
- Icelandic
  (PDF/1.13 MB)
- Italian
  (PDF/1.13 MB)
- Latvian
  (PDF/1.21 MB)
- Lithuanian
  (PDF/1.17 MB)
- Maltese
  (PDF/1.22 MB)
- Norwegian
  (PDF/1.13 MB)
- Polish
  (PDF/1.22 MB)
- Portuguese
  (PDF/1.13 MB)
- Romanian
  (PDF/1.16 MB)
- Slovak
  (PDF/1.22 MB)
- Slovenian
  (PDF/1.2 MB)
- Spanish
  (PDF/1.13 MB)
- Swedish
  (PDF/1.13 MB)

Telmisartan Teva

Table of contents

Overview

Telmisartan Teva : EPAR - Summary for the public (PDF/646.62 KB)

Authorisation details

Product information

Telmisartan Teva : EPAR - Product Information (PDF/1.14 MB)

Telmisartan Teva : EPAR - All Authorised presentations (PDF/581.99 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Telmisartan Teva : EPAR - Procedural steps taken and scientific information after authorisation (PDF/765 KB)

Telmisartan Teva-H-C-1146-A31-0010 : 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 PRAC recommendation (PDF/609.6 KB)

Telmisartan Teva-H-C-1146-A31-0010 : EPAR - Assessment Report - Article 31 (PDF/1.07 MB)

Initial marketing-authorisation documents

Telmisartan Teva : EPAR - Public assessment report (PDF/939.21 KB)

CHMP summary of positive opinion for Telmisartan Teva (PDF/638.36 KB)

News

More information on Telmisartan Teva

Public statement on Telmisartan Teva : Withdrawal of the marketing authorisation in the European Union (PDF/125.54 KB)

Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer (PDF/511.41 KB)

Questions and answers on generic medicines (PDF/66.45 KB)

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