PritorPlus

RSS

telmisartan / hydrochlorothiazide

Authorised
This medicine is authorised for use in the European Union.

Overview

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 26/02/2019

Authorisation details

Product details
Name
PritorPlus
Agency product number
EMEA/H/C/000414
Active substance
  • telmisartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
telmisartan / hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DA07
Publication details
Marketing-authorisation holder
Bayer AG
Revision
33
Date of issue of marketing authorisation valid throughout the European Union
22/04/2002
Contact address

51368 Leverkusen
Germany

Product information

27/11/2018 PritorPlus - EMEA/H/C/000414 - IG/1011

Contents

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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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