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EMA Product

PritorPlus

Product approved by European Medicines Agency (EU)

Basic Information

PritorPlus

Regulatory Information

EMEA/H/C/000414

Authorised

April 22, 2002

39

January 17, 2025

Company Information

Germany

Kaiser-Wilhelm-Allee 1 51373 Leverkusen

BAYER AG

Active Substances Detail

Telmisartanhydrochlorothiazide

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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.

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