Telmisartan Teva Pharma

Authorised

This medicine is authorised for use in the European Union

telmisartan

Overview

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.

What is Telmisartan Teva Pharma?

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.

What is Telmisartan Teva Pharma used for?

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.

How is Telmisartan Teva Pharma used?

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.

How does Telmisartan Teva Pharma work?

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.

How has Telmisartan Teva Pharma been studied?

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.

What are the benefits and risks of Telmisartan Teva Pharma?

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.

Why has Telmisartan Teva Pharma been approved?

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.

Other information about Telmisartan Teva Pharma:

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.

Telmisartan Teva Pharma : EPAR - Summary for the public

Reference Number: EMA/684956/2011

Product information

Telmisartan Teva Pharma : EPAR - Product Information

Telmisartan Teva Pharma : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Telmisartan Teva Pharma
• Active substance:
  Telmisartan
• International non-proprietary name (INN) or common name:
  telmisartan
• Therapeutic area (MeSH):
  Hypertension
• Anatomical therapeutic chemical (ATC) code:
  C09CA07

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension in adults.

Authorisation details

• EMA product number:
  EMEA/H/C/002511
• 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.

• Marketing authorisation holder:
  Teva B.V.

  Swensweg 5; 2031GA Haarlem; The Netherlands

• Opinion adopted:
  21/07/2011
• Marketing authorisation issued:
  03/10/2011
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

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

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 ...

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

AdoptedReference Number: EMA/PRAC/294920/2014

Initial marketing authorisation documents

Telmisartan Teva Pharma : EPAR - Public assessment report

AdoptedReference Number: EMA/777686/2011

CHMP summary of positive opinion for Telmisartan Teva Pharma

AdoptedReference Number: EMA/CHMP/522766/2011