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EMA Approval

Telmisartan Teva Pharma

Teva B.V.,Swensweg 5,2031GA Haarlem,The Netherlands

October 3, 2011

Authorised

EMEA/H/C/002511

July 21, 2011

C09CA07

telmisartan

Agents acting on the renin-angiotensin system

telmisartan

Hypertension

Basic Information

EMEA/H/C/002511

Teva B.V.,Swensweg 5,2031GA Haarlem,The Netherlands

Authorised

October 3, 2011

July 21, 2011

C09CA07

telmisartan

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension in adults.

Special Designations

Generic Medicine

Overview Summary

This is a summary of the European public assessment report (EPAR) for Telmisartan Teva Pharma. 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 Teva Pharma.

Authorisations (1)

EMEA/H/C/002511

Teva B.V.,Swensweg 5,2031GA Haarlem,The Netherlands

Authorised

October 3, 2011

Active Substances (1)

Telmisartan

Documents (10)

Telmisartan Teva Pharma-H-C-2511-A31-0006 : EPAR - Assessment Report - Article 31

September 25, 2014

CHANGES_SINCE_INITIAL_AUTHORISATION

Telmisartan Teva Pharma : EPAR - All Authorised presentations

October 17, 2011

AUTHORISED_PRESENTATIONS

Telmisartan Teva Pharma : EPAR - Public assessment report

October 17, 2011

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for Telmisartan Teva Pharma

July 21, 2011

CHANGES_SINCE_INITIAL_AUTHORISATION

Telmisartan Teva Pharma : EPAR - Public assessment report

October 17, 2011

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

CHMP summary of positive opinion for Telmisartan Teva Pharma

July 21, 2011

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Telmisartan Teva Pharma : EPAR - Summary for the public

October 17, 2011

OVERVIEW_DOCUMENT

Telmisartan Teva Pharma-H-C-2511-A31-0006 : 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 ...

September 25, 2014

CHANGES_SINCE_INITIAL_AUTHORISATION

Telmisartan Teva Pharma : EPAR - Product Information

October 17, 2011

DRUG_PRODUCT_INFORMATION

Telmisartan Teva Pharma : EPAR - Procedural steps taken and scientific information after authorisation

August 9, 2012

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (8)

Question

What are the benefits and risks of Telmisartan Teva Pharma?

Answer

Because Telmisartan Teva Pharma 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.

Question

How is Telmisartan Teva Pharma used?

Answer

For the treatment of hypertension, the usual recommended dose of Telmisartan Teva Pharma is 40 mg once a day, but some patients may benefit from using a 20-mg dose. 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 Teva Pharma, 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.

Question

How does Telmisartan Teva Pharma work?

Answer

The active substance in Telmisartan Teva Pharma, 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.

Question

Other information about Telmisartan Teva Pharma:

Answer

The European Commission granted a marketing authorisation valid throughout the EU for Telmisartan Teva Pharma on 3 October 2011.

For more information about treatment with Telmisartan Teva Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Question

What is Telmisartan Teva Pharma?

Answer

Telmisartan Teva Pharma is a medicine that contains the active substance telmisartan. It is available as tablets (20 mg, 40 mg and 80 mg).

Telmisartan Teva Pharma is a ‘generic medicine’. This means that Telmisartan Teva Pharma is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Micardis.

Question

What is Telmisartan Teva Pharma used for?

Answer

Telmisartan Teva Pharma is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the hypertension has no obvious cause.

Telmisartan Teva Pharma 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.

Question

How has Telmisartan Teva Pharma been studied?

Answer

Because Telmisartan Teva Pharma 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.

Question

Why has Telmisartan Teva Pharma been approved?

Answer

The CHMP concluded that, in accordance with EU requirements, Telmisartan Teva Pharma 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 Teva Pharma be given marketing authorisation.

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