Kinzalkomb

Withdrawn

This medicine's authorisation has been withdrawn

telmisartan / hydrochlorothiazide

Overview

On 30 April 2026, the European Commission withdrew the marketing authorisation for Kinzalkomb (telmisartan / hydrochlorothiazide) 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. 

Kinzalkomb was granted marketing authorisation in the EU on 19 April 2002 for the treatment of essential hypertension. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2007. 

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

Kinzalkomb : EPAR - Summary for the public

Product information

Kinzalkomb : EPAR - Product Information

Kinzalkomb : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Kinzalkomb
• Active substance:
  • telmisartan
  • hydrochlorothiazide
• International non-proprietary name (INN) or common name:
  • telmisartan
  • hydrochlorothiazide
• Therapeutic area (MeSH):
  Hypertension
• Anatomical therapeutic chemical (ATC) code:
  C09DA07

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Kinzalkomb fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.

Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

Authorisation details

• EMA product number:
  EMEA/H/C/000415
• Marketing authorisation holder:
  Bayer AG

  51368 Leverkusen; Germany

• Marketing authorisation issued:
  19/04/2002
• Withdrawal of marketing authorisation:
  30/04/2026
• Revision:
  41

Assessment history

Changes since initial authorisation of medicine

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

Kinzalkomb-H-C-415-A31-0084 : 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 recomme...

CHMP post-authorisation summary of positive opinion for Kinzalkomb

Adopted Reference Number: EMA/CHMP/261191/2013

Kinzalkomb-H-C-415-X-0039 : EPAR - Scientific Discussion - Extension

Adopted

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

Initial marketing authorisation documents

Kinzalkomb-H-C-415-A31-0084 : EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/PRAC/294920/2014

Kinzalkomb : EPAR - Scientific Discussion

Kinzalkomb : EPAR - Procedural steps taken before authorisation