telmisartan / amlodipine
This is a summary of the European public assessment report (EPAR) for Twynsta. 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 Twynsta.
Twynsta : EPAR - Summary for the public (PDF/83.49 KB)
First published: 19/10/2010
Last updated: 08/10/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Boehringer Ingelheim International GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
23/06/2019 Twynsta - EMEA/H/C/001224 - IB/0039
- 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 in adults:
Twynsta is indicated in adults whose blood pressure is not adequately controlled on amlodipine.
Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.