Twynsta
telmisartan / amlodipine
Table of contents
Overview
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.
Authorisation details
Product details | |
---|---|
Name |
Twynsta
|
Agency product number |
EMEA/H/C/001224
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Hypertension
|
Anatomical therapeutic chemical (ATC) code |
C09DB04
|
Publication details | |
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Marketing-authorisation holder |
Boehringer Ingelheim International GmbH
|
Revision |
12
|
Date of issue of marketing authorisation valid throughout the European Union |
07/10/2010
|
Contact address |
Binger Strasse 173
D-55216 Ingelheim am Rhein Germany |
Product information
22/12/2021 Twynsta - EMEA/H/C/001224 - N/0044
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Pharmacotherapeutic group
Agents acting on the renin-angiotensin system
Therapeutic indication
Treatment of essential hypertension in adults:
Add-on therapy
Twynsta is indicated in adults whose blood pressure is not adequately controlled on amlodipine.
Replacement therapy
Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.
Assessment history
News
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17/05/2013
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26/04/2013
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
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20/10/2011