Twynsta

RSS

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 23/08/2019

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
10
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

23/06/2019 Twynsta - EMEA/H/C/001224 - IB/0039

Contents

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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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