Onduarp

RSS

telmisartan / amlodipine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Onduarp has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 02/04/2014

Authorisation details

Product details
Name
Onduarp
Agency product number
EMEA/H/C/002118
Active substance
telmisartan / amlodipine besilate
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
2
Date of issue of marketing authorisation valid throughout the European Union
24/11/2011
Contact address
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

Product information

17/02/2014 Onduarp - EMEA/H/C/002118 - WS/0236

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

CARDIOVASCULAR SYSTEM

Therapeutic indication

Treatment of essential hypertension in adults:

Add on therapy

Onduarp 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 Onduarp containing the same component doses.

Assessment history

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