telmisartan / hydrochlorothiazide
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.
PritorPlus : EPAR - Summary for the public (PDF/77.11 KB)
First published: 02/06/2009
Last updated: 12/11/2015
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23/06/2020 PritorPlus - EMEA/H/C/000414 - IG/1259
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Agents acting on the renin-angiotensin system
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive20/10/2011
European Medicines Agency recommendation on use of angiotensin-II-receptor antagonists during pregnancy24/04/2008