Onduarp
telmisartan / amlodipine
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Onduarp has been withdrawn at the request of the marketing-authorisation holder.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 | |
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Cardiovascular system
Therapeutic indication
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.