PritorPlus

Withdrawn

This medicine's authorisation has been withdrawn

telmisartan / hydrochlorothiazide

Overview

On 1 October 2025, the European Commission withdrew the marketing authorisation for PritorPlus (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. 

PritorPlus (SRD) was granted marketing authorisation in the EU on 22 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.

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

PritorPlus : EPAR - Summary for the public

Product information

PritorPlus : EPAR - Product Information

PritorPlus : EPAR - All Authorised presentations

Product details

• Name of medicine:
  PritorPlus
• 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.

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

PritorPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus (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/000414
• Marketing authorisation holder:
  Bayer AG

  51368 Leverkusen; Germany

• Marketing authorisation issued:
  22/04/2002
• Withdrawal of marketing authorisation:
  01/10/2026
• Revision:
  39

Assessment history

Changes since initial authorisation of medicine

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

PritorPlus-H-C-414-A31-0093 : EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/PRAC/294920/2014

PritorPlus-H-C-414-A31-0093 : 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 PritorPlus

Adopted Reference Number: EMA/CHMP/261191/2013

PritorPlus-H-C-414-X-0042 : EPAR - Scientific Discussion - Extension

Adopted

Initial marketing authorisation documents

PritorPlus : EPAR - Scientific Discussion

PritorPlus : EPAR - Procedural steps taken before authorisation