This is a summary of the European public assessment report (EPAR) for MicardisPlus. 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 MicardisPlus.
MicardisPlus : EPAR - Summary for the public (PDF/75.62 KB)
First published: 06/05/2009
Last updated: 10/11/2015
|Agency product number||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Boehringer Ingelheim International GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
55216 Ingelheim am Rheim
24/08/2022 MicardisPlus - EMEA/H/C/000413 - IG1549
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Agents acting on the renin-angiotensin system
Treatment of essential hypertension.
MicardisPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
MicardisPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on MicardisPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.