DuoPlavin

RSS

clopidogrel / acetylsalicylic acid

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

Overview

This is a summary of the European public assessment report (EPAR) for DuoPlavin. 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 DuoPlavin.

This EPAR was last updated on 10/12/2018

Authorisation details

Product details
Name
DuoPlavin
Agency product number
EMEA/H/C/001143
Active substance
  • clopidogrel
  • acetylsalicylic acid
International non-proprietary name (INN) or common name
clopidogrel / acetylsalicylic acid
Therapeutic area (MeSH)
  • Acute Coronary Syndrome
  • Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AC30
Publication details
Marketing-authorisation holder
Sanofi Pharma Bristol-Myers Squibb SNC
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
14/03/2010
Contact address
54, rue La Boétie
F-75008 Paris
France

Product information

25/10/2018 DuoPlavin - EMEA/H/C/001143 - WS/1433

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

Antithrombotic agents

Therapeutic indication

DuoPlavin is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in:

  • non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention;
  • ST-segment-elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy.

Assessment history

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