Telmisartan Actavis

telmisartan

Overview
Authorisation details
Product information
Assessment history

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.

: Telmisartan Actavis is a medicine that contains the active substance telmisartan. It is available as tablets (20 mg; 40 and 80 mg).
Telmisartan Actavis is a ‘generic medicine’. This means that Telmisartan Actavis is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Micardis.

: Telmisartan Actavis is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the hypertension has no obvious cause.
Telmisartan Actavis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes. It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
The medicine can only be obtained with a prescription.

: For the treatment of essential hypertension, the usual recommended dose of Telmisartan Actavis is 40 mg once a day, but some patients may benefit from using 20mg once a day. If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day. The doctor should monitor the patient’s blood pressure closely when starting Telmisartan Actavis, and may decide to adjust the patient’s blood-pressure-lowering medication. Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day. Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.

: The active substance in Telmisartan Actavis, telmisartan, is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke. It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.

: Because Telmisartan Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

: Because Telmisartan Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

: The CHMP concluded that, in accordance with EU requirements, Telmisartan Actavis has been shown to have comparable quality and to be bioequivalent to Micardis. Therefore, the CHMP’s view was that, as for Micardis, the benefit outweighs the identified risk. The Committee recommended that Telmisartan Actavis be given marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the European Union for Telmisartan Actavis on 30 September 2010.
For more information about treatment with Telmisartan Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Telmisartan Actavis : EPAR - Summary for the public (PDF/70.58 KB)

First published: 20/10/2010
Last updated: 28/07/2015
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This EPAR was last updated on 24/10/2023

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 and hybrid medicines.

Publication details
Marketing-authorisation holder	Actavis Group PTC ehf
Revision	13
Date of issue of marketing authorisation valid throughout the European Union	29/09/2010
Contact address	Dalshraun 1 220 Hafnarfjörður Iceland

Product information

23/10/2023 Telmisartan Actavis - EMEA/H/C/001168 - N/0029

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Telmisartan Actavis : EPAR - Product Information (PDF/364.69 KB)

First published: 20/10/2010
Last updated: 24/10/2023
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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.

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Telmisartan Actavis : EPAR - All Authorised presentations (PDF/28.13 KB)

First published: 20/10/2010
Last updated: 14/11/2011
- Bulgarian
  (PDF/41.72 KB)
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  (PDF/36.61 KB)
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- Spanish
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- Swedish
  (PDF/21.15 KB)

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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Telmisartan Actavis : EPAR - Procedural steps taken and scientific information after authorisation (PDF/140.64 KB)

First published: 14/11/2011
Last updated: 24/10/2023
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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
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- Spanish
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- Swedish
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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

Telmisartan Actavis

Table of contents

Overview