Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)

Withdrawn

This medicine's authorisation has been withdrawn

telmisartan

Overview

On 30 April 2026, the European Commission withdrew the marketing authorisation for Kinzalmono (telmisartan) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Bayer AG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Kinzalmono was granted marketing authorisation in the EU on 16 December 1998 for treatment of essential hypertension and reduction of cardiovascular morbidity in adults with manifest atherothrombotic cardiovascular disease or type 2 diabetes mellitus with documented target organ damage. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2003. It was then granted unlimited validity in 2008.

Kinzalmono was a duplicate application to Micardis, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Micardis.

Kinzalmono : EPAR - Summary for the public

Product information

Kinzalmono : EPAR - Product Information

Kinzalmono : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000211
• Marketing authorisation holder:
  Bayer AG

  51368 Leverkusen; Germany

• Opinion adopted:
  23/07/1998
• Marketing authorisation issued:
  16/12/1998
• Withdrawal of marketing authorisation:
  30/04/2026
• Revision:
  32

Assessment history

Changes since initial authorisation of medicine

Kinzalmono : EPAR - Procedural steps taken and scientific information after authorisation

Kinzalmono : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/PRAC/294920/2014

Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scie...

CHMP post-authorisation summary of positive opinion for Kinzalmono

Adopted Reference Number: EMA/CHMP/261191/2013

Kinzalmono-H-C-211-WS-0254 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/549534/2012

Kinzalmono-H-C-211-II-0072 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/768467/2009

CHMP post-authorisation summary of positive opinion for Kinzalmono on 22 October 2009

Adopted Reference Number: EMEA/CHMP/681835/2009

Kinzalmono : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Kinzalmono : EPAR - Scientific Discussion

Kinzalmono : EPAR - Procedural steps taken before authorisation