Telmisartan Teva

Withdrawn

This medicine's authorisation has been withdrawn

telmisartan

Overview

On 19 May 2021, the European Commission withdrew the marketing authorisation for Telmisartan Teva (telmisartan) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Telmisartan Teva was granted marketing authorisation in the EU on 26 January 2010 for the treatment of essential hypertension. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. 

Telmisartan Teva is a generic medicine of Micardis. There are other generic medicinal products of Micardis authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Telmisartan Teva is updated to indicate that the marketing authorisation is no longer valid.

Telmisartan Teva : EPAR - Summary for the public

Product information

Telmisartan Teva : EPAR - Product Information

Telmisartan Teva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Telmisartan Teva
• 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/001146
• 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:
  19/11/2009
• Marketing authorisation issued:
  25/01/2010
• Revision:
  11

Assessment history

Changes since initial authorisation of medicine

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

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

Telmisartan Teva-H-C-1146-A31-0010 : EPAR - Assessment Report - Article 31

AdoptedReference Number: EMA/PRAC/294920/2014

Initial marketing authorisation documents

Telmisartan Teva : EPAR - Public assessment report

CHMP summary of positive opinion for Telmisartan Teva

AdoptedReference Number: EMEA/CHMP/267262/2009