Copalia
amlodipine / valsartan
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Copalia. 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 Copalia.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Authorisation details
Product details | |
---|---|
Name |
Copalia
|
Agency product number |
EMEA/H/C/000774
|
Active substance |
|
International non-proprietary name (INN) or common name |
amlodipine / valsartan
|
Therapeutic area (MeSH) |
Hypertension
|
Anatomical therapeutic chemical (ATC) code |
C09DB01
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
15/01/2007
|
Contact address |
Product information
16/07/2019 Copalia - EMEA/H/C/000774 - IG/1116/G
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
Therapeutic indication
Treatment of essential hypertension.
Copalia is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Assessment history
News
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28/06/2013
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17/05/2013
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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
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24/04/2008