Twynsta

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telmisartan / amlodipine

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 10/01/2022

Authorisation details

Product details
Name
Twynsta
Agency product number
EMEA/H/C/001224
Active substance
  • telmisartan
  • amlodipine
International non-proprietary name (INN) or common name
  • telmisartan
  • amlodipine
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DB04
Publication details
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

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Product information documents contain:

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

Changes since initial authorisation of medicine

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