telmisartan / hydrochlorothiazide

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for PritorPlus. 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 PritorPlus.

This EPAR was last updated on 14/09/2022

Authorisation details

Product details
Agency product number
Active substance
  • telmisartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
  • telmisartan
  • hydrochlorothiazide
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Bayer AG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Kaiser-Wilhelm-Allee 1
51373 Leverkusen

Product information

24/08/2022 PritorPlus - EMEA/H/C/000414 - IG1549

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

Changes since initial authorisation of medicine

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