Telmisartan Actavis

telmisartan

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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.

What is 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.

What is Telmisartan Actavis used for?

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.

How is Telmisartan Actavis used?

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.

How does Telmisartan Actavis work?

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.

How has Telmisartan Actavis been studied?

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.

What are the benefits and risks of Telmisartan Actavis?

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.

Why has Telmisartan Actavis been approved?

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.

Other information about Telmisartan Actavis

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.

Name Language First published Last updated
Telmisartan Actavis : EPAR - Summary for the public BG = bălgarski 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public ES = español 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public CS = čeština 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public DA = dansk 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public DE = Deutsch 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public ET = eesti keel 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public EL = elliniká 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public EN = English 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public FR = français 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public IT = italiano 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public LV = latviešu valoda 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public LT = lietuvių kalba 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public HU = magyar 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public MT = Malti 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public NL = Nederlands 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public PL = polski 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public PT = português 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public RO = română 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public SK = slovenčina 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public SL = slovenščina 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public FI = suomi 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public SV = svenska 2010-10-20 2015-07-28
Telmisartan Actavis : EPAR - Summary for the public HR = Hrvatski 2010-10-20 2015-07-28

This EPAR was last updated on 05/04/2018 .

Authorisation details

Product details

Product details for Telmisartan Actavis
NameTelmisartan Actavis
Agency product numberEMEA/H/C/001168
Active substance

telmisartan

International non-proprietary name (INN) or common name

telmisartan

Therapeutic area Hypertension
Anatomical therapeutic chemical (ATC) code C09CA07
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Telmisartan Actavis
Marketing-authorisation holder

Actavis Group PTC ehf

Revision8
Date of issue of marketing authorisation valid throughout the European Union30/09/2010

Contact address:

Actavis Group PTC ehf
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

Product information

20/03/2018  Telmisartan Actavis -EMEA/H/C/001168 -N/0017

Name Language First published Last updated
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05
Telmisartan Actavis : EPAR - Product Information HR = Hrvatski 2010-10-20 2018-04-05

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.


Name Language First published Last updated
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14
Telmisartan Actavis : EPAR - All Authorised presentations HR = Hrvatski 2010-10-20 2011-11-14

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

Name Language First published Last updated
Telmisartan Actavis : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2011-11-14 2018-04-05
Telmisartan Actavis-H-C-1168-A31-0007 : EPAR - Assessment Report - Article 31 HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  
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 PRAC recommendation HR = Hrvatski 2014-09-29  

Initial marketing-authorisation documents

Name Language First published Last updated
Telmisartan Actavis : EPAR - Public assessment report HR = Hrvatski 2010-10-20  
CHMP positive summary of opinion for Telmisartan Actavis HR = Hrvatski 2010-06-25  

Authorised

This medicine is approved for use in the European Union

More information on Telmisartan Actavis